BSI_April 2016_Raj Gunashekar

1An MM Activ Publication | www.biospectrumindia.com | April 2016 | BioSpectrum
Volume 14  Issue 4  April 2016 www.biospectrumindia.com
An Publication
`100
Totalpagesincludingcover84
India’s
trillion-dollar
opportunities
in ICT, IoT
LATEST
BIOSUPPLIER
TECHNOLOGIES
LATEST
BIOSUPPLIER
TECHNOLOGIES
LATEST
BIOSUPPLIER
TECHNOLOGIES
BIOTALK
Padma Shri
Awardee,
Prof. Dipankar
Chatterji
BIOTALK
Padma Shri
Awardee,
Prof. Veena
Tandon
BIOTALK
Padma Bhushan
Awardee,
Dr Alla Venkata
Rama Rao
ARTICLES BY
THE INDUSTRY CAPTAINS

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4 BioSpectrum | April 2016 | www.biospectrumindia.com | An MM Activ Publication
Volume 14  Issue 4  April 2016 www.biospectrumindia.com
An Publication
`100
India’s
trillion-dollar
opportunities
in ICT, IoT
LATEST
BIOSUPPLIER
TECHNOLOGIES
LATEST
BIOSUPPLIER
TECHNOLOGIES
LATEST
BIOSUPPLIER
TECHNOLOGIES
BIOTALK
Padma Shri
Awardee,
Prof. Dipankar
Chatterji
BIOTALK
Padma Shri
Awardee,
Prof. Veena
Tandon
BIOTALK
Padma Bhushan
Awardee,
Dr Alla Venkata
Rama Rao
ARTICLES BY
THE INDUSTRY CAPTAINS
COVER
DESIGN BY:
SHIHAB K A
BioContents
REGULARS
7BIOEDIT
8BIOMAIL
10BIONEWS
62BIOSUPPLIERS
65BIOPEOPLE
COVERSTORY 20
BIOANALYSIS
BIOTALK
INTRODUCING THE ‘PFIZERKLINE EMPIRE’57
QE PRIZE WINNER DR LANGER
SHARES HIS SUCCESS
Dr Robert Langer
Winner of Queen Elizabeth Prize of Engineering 2015,
David H Koch Institute Professor, MIT, USA
16
464851
Latest
BioSupplier
Technologies
2016 Padma Shri Awardee
Prof. Dipankar Chatterji
2016 Padma Shri Awardee,
Prof. Veena Tandon
2016 Padma Bhushan Awardee,
Dr Alla Venkata Rama Rao
‘We have
performed
extraordinarily
well’
‘I did not want
to follow the
convention’
Scientific Research
and Entrepreneurship
does not go hand-in-
hand
BIOSPECTRUM IS
PUBLISHING A SELECTION
OF OPEN INVITATION
ARTICLES BY THE
INDUSTRY CAPTAINS,
HIGHLIGHTING THE
LATEST BIOSUPPLIER
TECHNOLOGIES/
PRODUCTS THAT
ARE ENABLING THE
BIOSCIENCES INDUSTRY
ON THE COURSE OF DRUG
DISCOVERY.

BioContents
BIOIT
INDIA’S TRILLION-DOLLAR
OPPORTUNITIES IN ICT, IOT
68
BIOCLUSTER
SCIENTISTS WELCOME NATIONAL
BIOTECHNOLOGY DEVELOPMENT
STRATEGY
54
Satyen Mohapatra
Madavan Vasudevan, Hitesh Goswami and
Rohit Nandan Shukla., cofounders
Dr Sudha Rao, Founder Director, Dhiti Omics
‘BELIEVE AND
TAKE THE LEAP
OF FAITH’
DEGREES FROM BEST SCHOOLS
IS NO GUARANTEE FOR
ENTREPRENEURIAL SUCCESS
72
80
BIOPRENEUR
BIOEVENT
ENVISIONING NANO
HORIZONS
BIOPHARMA HEALTHCARE
SUMMIT ON JUNE 2 IN US
60
66
BANGALORE INDIA NANO 2016

F
ourteen years ago,
in March 2002, In-
dia unleashed the
power of technol-
ogy to Indian farm-
ers by allowing first
commercial cultivation of geneti-
cally-modified (GM) crops.
But 14 years later, March 2016,
the Indian government has
sought to roll back the same
gains made by technology by unleashing arbi-
trary state power in twin actions that seek to
undermine the fledgling biotech industry.
And the twin government actions targeting the
industry came within 48 hours of each other.
On March 10, the government notified a sharp
74 percent reduction in trait fee (technology
fee) charged by Bt cotton developer Monsanto
on all the Bt cotton seeds sold by it from Rs 163
per pack to Rs 43. Also, the price of 450 gm
packet of Bt cotton seed was fixed at Rs 800.
The prevailining market prices of more than
200 varieties of cotton hybrids that carried the
Bt gene ranged from Rs 830 to 1,200.
Monsanto has got a stay order on this action
from Karnataka High Court. The world’s leading
seed company has threatened to even pull out of
the country over this issue jeopardizing the bil-
lions of dollars invested in the RD center and
extension networks over the past three decades.
Such an action is throwback to the 1970 when
two leading MNCs, IBM and Coca-Cola were
thrown out of the country amidst nationalistic
fervor. These two companies have come back
so strongly that they are employers of thou-
sands of people in the country and among the
most trusted brands now.
Prime Minister Narendra Modi’s ministers
spouting similar sentiments and Monsanto’s
technology will be replaced by indigenous Bt
cotton seeds are sheer bravado, not rooted in
realism. The few GM technologies developed in
Indian laboratories have been starved of funds
for more than 15 years even to carry out man-
datory field trials to seek regulatory approval
for commercial cultivation.
Monsanto needs the Indian market, the world’s
second largest cotton grower, as much as the
country needs this technology at the moment.
The sensible thing to do is fast track develop-
ment of indigenous technologies and let them
compete in the global marketplace. Resorting to
arbitrary state power in the world’s fast growing
economy is certainly not a sign of strength.
The second government action happened on
March 12, 2016 when the Chandrakant Kokate
(VC, KLE University, Belgaum) report on fixed
dose combination (FDC) drugs was pulled out
of the freezer and used to instantly ban 344
drug combinations that have become the main-
stay for Indian patients for decades. The Ko-
kate report, prepared by the expert committee,
was with the government since January 2015.
Why March 12, 2016 was chosen to shock the
nation is a question which has no convincing
answer. The Kokate committee has done a good
job on this contentious issue in less than two
years. There are many differing views on these
combinations. The right thing to do would
have been to put the report in public domain,
initiate wide ranging discussions and prepare
the ground for subsequent action. Such a step
would have helped the society better.
A nation seeking global investments should
refrain from arbitrary actions that undermine
business confidence. India’s open society that
assimilates the best from around the world for
millennia deserves better. BS
Narayanan Suresh
Group Editor
narayanan.suresh@mmactiv.in
Price control, arbitrary bans threaten
to unravel the biotech industry
BioEdit
*********

Vol 14; Issue 3; March 2016
Startlingstart-ups
The cover story on biotech start-ups wastimely.We do
hear aboutstartups in commerce and IT on a daily basis.
It was good to see biotech is not behind andthesefirms
are coming up with novel ideas.It will definitely give the
much needed push to the sector andcontribute to ‘DBT’s
$100 bn by 2020’ project besides solving health woos of
the country.
-Payal Mukherjee, Bangalore
Cloud computing
This has reference to the story on cloud computing in the
last issue of BioSpectrum.IT has disrupted all sectors and
life sciences is not far behind.This certainly is an era of
cloud computing and the life science firms should move
ahead and adopt cloud-based systems.The cover story on
the start-ups made forinteresting and inspiring read.
- Priyansh Sen, Ahmedabad
Bravo BioSpectrum
I would like to applaud BioSpectrum for doing a com-
mendable job of highlightingstartupsinbiotech.Iwas
amazed to see the number of startups in the biotech field.
It certainly dispels the myth that funding is a hindrance in
this field because of longer gestation period.DBT and BI-
RAC are doing a good job by supporting biotech startups.
-Aditya Mahajan, Hyderabad
Highlight scientific research
My heartiest congratulations to the entire BioSpectrum
team to come up with such a wonderful and inspiring anni-
versary issue. Just a request, it would be great if BioSpec-
trum also take an initiative to publish about the research
in the country, more frequently. It would help in highlight-
ing scientific research in the country and re-energize the
scientists as the research news seldom makes headlines.
Ankit Mehra, Noida
BIOSPECTRUMRECREATINGTHESILICONVALLEYININDIAMARCH2016
Volume 14  Issue 3  March 2016 www.biospectrumindia.com
An Publication
`100
India at the moment
is at this cusp.
RECREATING THE
SILICON VALLEY
IN INDIA
What’s
trending in
Indian Biotech
13TH
ANNIVERSARY SPECIAL
Vol 14; Issue 4; April 2016
Publisher: Jagdish Patankar
Editorial
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Editor: Srinivas Rao Chandan
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BioNews
Novartis launches
the first IL-17A
inhibitor to receive
approval in India
Novartis Healthcareannounced the
launch of Scapho (secukinumab)150
mg, for the treatment of moderate-
to-severe plaque psoriasis in adult
patients. Scapho is an injectable
medicine and the first interleukin-
17A (IL-17A) inhibitor to be approved
in India.This approval marks a sig-
nificant milestone in the treatment
of psoriasis, providing a new and im-
portant first-line biologic treatment
option for patients who are candi-
dates for systemic therapy.
Secukinumab was developed for
the treatment of moderate to severe
plaque psoriasis in adult patients
who are candidates for systemic ther-
apy with a recommended dose of 300
mg.Secukinumab has demonstrated
a statistically significant improve-
ment in clearing psoriatic lesions as
early as 3 weeks.
“This is ground breaking news as
clear skin can now be a reality for pa-
tients struggling to cope with psoria-
sis,” said DrAnchala Parthasaradhi,
Director, Anchala Skin Institute, Hy-
derabad. “Most psoriasis patients are
not content with current therapy op-
tions including the earlier biologics
and there is a significant unmet need.
Secukinumab seems to be a promis-
ing treatment for psoriasis and can
provide patients a better chance of
achieving clear or almost clear skin.”
BioNews
Sun appoints Dhoni as Revital H
brand ambassador
Sun Pharma’s Global Consumer
Healthcare business announced-
MSDhoni as the new brand am-
bassador of Revital H. MSDhoni
emerged as a popular choice based
on aconsumer research conducted
by the company.MS Dhoni is a
cricketer known for pushing lim-
its and achieving more and a per-
fect combination of physical fitness,strategic thinking and decision mak-
ing and fits well in the active lifestyle value proposition of Revital H brand.
The brand has a strong hold on North, Central and East part of India and
seeks to strengthen its market presence in West and South India.
Twenty-five years following its launch in the Indian market, Revital H,
India’s leading health supplement gets a new makeover. Sun Pharma’s
Global Consumer Healthcare is repositioning its iconic brand for active
lifestyle and being ‘fit and active’. This repositioning follows a compre-
hensive research undertaken by the company to understand changing
consumer needs. The Vitamin and Dietary Health Supplement market in
India is estimated to be Rs 8,828 crore and growing at 12 percent with top
10 brands (of which Revital H is a part) in the category contributing almost
48 percent of the market revenue.
Glenmark receives tentative
approval for new generic
Glenmark Pharmaceuticals USA (Glenmark) has been granted tentative
approval by the United States Food and Drug Administration (US FDA)
for its Lacosamide Oral Solution, 10 mg/mL, the generic version of Vimpat
Oral Solution, 10 mg/mL of UCB.
Glenmark will market this product upon receiving final approval of its
Lacosamide Oral Solution, 10 mg/mL ANDA. The patent listed in the Or-
ange Book for Vimpat Oral Solution, 10 mg/mL is scheduled to expire on
March 17,2022.
According to IMS Health sales data for the 12-month period ending Janu-
ary 2016, the Vimpat market achieved annual sales of approximately $55.4
million.

BioNews
Torrent Pharma’s Dahej plant receives EIR from FDA
Prior to this approval, the plant
has also received approval from
EU Germany.It was set up to
cater mainly to the regulated in-
ternational markets such as US,
Brazil, Germany etc.
With the approval, this plant
is now the 3rdplant of Torrent
Pharma to receive US FDA ap-
proval, out of its 5 manufactur-
ing units.The company’s other
US FDA approved plant include
the plant at Indrad, Gujarat and
Pithampur (Indore), MP.
The plant is spread across 70
acres with a built up area of
around 97,000 sq. mtr.Phase
I has an installed capacity of
about 7,500 million tablets/cap-
sules and 25 MT API per annum.
As per the company, construc-
tion of phase II will commence
soon and once commissioned
the total capacity will increase
to about 14,000 million tablets/
capsules and 80 MT API per
year.
Aurobindo Pharma gets FDA okay for sodium tablets
Aurobindo Pharma is pleased to announce that the com-
pany has received final approval from the US Food and
Drug Administration (USFDA) to manufacture and mar-
ket Naproxen Sodium Tablets USP, 220 mg (OTC).This
product is expected to be launched in Q1 FY16-17.
The approved ANDA is bioequivalent and therapeutically
equivalent to the reference listed drug product (RLD)
Aleve Tablets, of Bayer Healthcare.
Naproxen sodium tablets is used in the treatment and pre-
vention of osteoporosis in postmenopausal women.The ap-
proved product has an estimated market size of $96 million
for the 12 months ending January 2016 according to IMS.
Pfizer launches Gelusil sachet
Pfizer’s GEP (Global Established Products) division in
India announced the launch of its largest selling antacid
Gelusil liquid in a ready-to-drink, on-the-go sachet for-
mat.The sachet aims to reach out to consumers who are
constantly on the go and have to rely on mul-
tiple elements of cure to
settle the acidity attacks.
Being rolled out in metros,
smaller towns and rural
areas simultaneously, the
Gelusil sachet is available
across pharmacy stores and
is priced at Rs 8per sachet.
Commenting on this launch,
Mr Partha Ghosh, senior di-
rector (Global Established
Products) said, “Acidity can be a recurring condi-
tion which can strike anyone, anytime, anywhere. It can
cause heartburn and serious discomfort which can im-
pact normal work. Research reveals that many who suffer
from acidity do not take it seriously and either ignore it or
resort to traditional methods to deal with acidity attacks.
While traditional methods may provide
symptomaticrelief,it does not ad-
dress the real issue.
Gelusil’s balanced formula not
only provides instant relief by
neutralizing the acid secreted
but also provides long lasting
relief by protecting the stom-
ach lining from damage due to
excessive acid.”
This newly launched easy-to-carry
sachet has a unique proposition of a ready-to-consume
solution for acidity that does not require water or a glass.
Itstamperproof packaging makes it convenient to carry
and consume it just anytime/anywhere.

BioNews
Cipla invests extra $3 mn in
Chase Pharmaceuticals
“Cipla (EU),UK (‘Cipla UK’),a wholly owned subsidiary of
the company, has pursuant to the approval of the board
of Cipla UK, made an additional investment of $3 mil-
lion in Chase Pharmaceuticals Corporation US (‘Chase’)
towards full settlement of its obligation under the agreed
arrangement for investment in Chase,”Cipla said in a fil-
ing to BSE
“Consequently, Cipla UK’s total investment in Chase
would aggregate to approximately $5.12 million for a 16.7
percent stake on a fully diluted basis,” it added.
The company in May 2014 had invested $1.5 million to
acquire 14.6 percent stake in Chase Pharmaceuticals.
APAC market to offer huge
opportunities in Cell Analysis
Cell analysis plays a major role in gene identification,
protein identification, transcription analysis and epig-
enomics at cellular level.
It proves to be an ultra-sensitive device to elucidate spe-
cific molecular processes and pathways and reveal the na-
ture of cell heterogenecity.
Hospitals, academic institutions, government bodies, as
well as pharmaceutical and biotechnology firms are in-
creasing their focus on application of cell analysis as a
modern emerging tool in research, drug discovery and
diagnosis.
The cell analysis techniques global market is segmented
into molecular approaches, image-based approaches and
others.
The molecular approaches include the PCR, NGS and
Microfluidics, cell isolation separation techniques per-
formed at cells genomic level, whereas the image-based
approaches include microscopes, FISH, FRAP, tracking,
high content screening (HCS), cytometrytechniques etc.
Biocon inks agreement with Lab PiSA for rh-insulin in USA
Biocon announced that its wholly owned subsidiary Bio-
con SA has entered into an agreement with Laboratorios
PiSA S.A. de C.V (PiSA) of Mexico forco-development
and commercializationof generic recombinant human in-
sulin (rh-insulin) for the US market.
This collaboration is a part of Biocon’s strategy to address
the large demand for generic rh-insulin in the US,which
accounts for over 40% of the global sales of $5 billion.
This is an extension of the company’s long standing
relationship of over 10 years with its trusted partner,
PiSA,who has a dominant position in insulins in Mexico.
Biocon’s insulin glargine was the first to be approved in
Mexico in 2015, as per the new bio-comparable approvals
pathway. Both companies are committed to providing af-
fordable access to insulins to patients.
This is a cost and profit sharing agreement with Biocon
responsible for clinical development, regulatory approv-
als, and commercialization of the product in the US.
This partnership will leverage Biocon’s manufacturing
facilities for the drug substance and PiSA’s drug product
facilities in Mexico. Furthermore, this arrangement will
take advantage of Pisa’s proximity to the US market and
Mexico’s NAFTA membership,which will ensure an effi-
cient and optimal supply chain to address the needs of
the US healthcare system for an affordable, high quality
rh-insulin.
Biocon’s global clinical development experience with
Insulin Glargine for the US will be a useful precedent in
developing rh-insulin for the US market.Through this
collaboration,we will introduce rh-insulin under the Bio-
con brand to address the$2 billion market opportunity
in the US.
Biocon Chairperson MD Kiran Mazumdar-Shaw said:
“Our partnership with PiSA demonstrates our commit-
ment to provide access to affordable insulins to patients
in the US. This collaboration will enable us to manufac-
ture the rh-insulin drug product at PiSA’s facilities.”

91-22-41515151 / 41515111
info@nilsan-nishotech.com
janhavi@nilsan-nishotech.com
Nilsan Nishotech Systems Pvt Ltd
Plot No. -199E,MIDCThane Belapur Road,
Khairane, Navi Mumbai 400 705

BioNews
India becomes
second EMBO
Associate
Member State
The Government of India through the
Department of Biotechnology (DBT),
Ministry of Science and Technology,
EMBO and its inter-governmental
funding body, the European Mo-
lecular Biology Conference (EMBO),
have signed a cooperation agreement
to strengthen scientific interaction
and collaborative research between
India and Europe.After the signing of
an agreement with Singapore in July
2015,India will now become the sec-
ond country to acquire the status of
EMBC Associate Member State.
The goal of the agreement is to boost
Indo-European exchange and to pro-
vide a platform for interaction with
top-level scientists on both sides.
As an EMBC Associate Member
State, researchers workinginIndia
are now eligible to participate in all
EMBO programmesand activities.In-
dian scientists can apply to EMBO’s
programmes,such as long-term fel-
lowships for postdoctoral research-
ers, short-term fellowships, courses
and workshops, as well as the EMBO
Young Investigator Programme.At
the same time, Europe will benefit
from networking with the top-level
scientists in India’s research com-
munity. Deeper cooperation between
nations will stimulate vision, ideas,
and provide a framework for a long-
term partnership.
“Through EMBO, we will not only
have the excellent joint programmes
that benefit India and Europe, but
we hope to be a magnet that attracts
bright young people to science from
in- and outside India,” said Professor
K VijayRaghavan, secretary of DBT,
for the Government of India.
Strides acquire 3 brands from
Moberg Pharma for $10 mn
Strides Shasunannounced that its wholly-owned subsidiary Strides Pharma-
has entered into an agreement with Moberg Pharma, Sweden, and its affili-
ates to acquire Jointflex, Fergon and Vanquish brands for a total consider-
ation of $10 million plus inventory value at closing.
The transaction adds $6.1 million of revenueand delivers above company
EBITDA margins.Recent acquisitions has enabled Strides Shasun build an
emerging OTC franchise both in its regulated and emerging markets.
The announced acquisition strengthens Strides Shasun’s strategy to build a
global OTC franchise.The OTC portfolio now includes market leading Chem-
ists Own umbrella brand in Australia and Nuprin in the US, acquired by erst-
while Shasun from Scolr Pharma, US.
Nuprin has the global rights to the first Ibuprofen 12-hour Extended-Release
(ER) tablets, as well as the associated Controlled Delivery Technology (CDT).
The company has also filed ANDA’s that will further enhance the OTC port-
folio in the US.
Once-a-week drug for
Type 2 diabetes launched
Eli Lilly and Company announced the launch of its recently approved dia-
betes treatment Trulicity (dulaglutide) in India.Trulicity is the first once-
weekly,injectable medication designed to improve blood sugar control in
adults with type 2 diabetes.
Trulicity is part of a class of drugs known as a glucagon - like peptide (GLP-1)
receptor agonists. It is not insulin and mimics the effects of GLP-1, a natural
hormone that helps keep blood sugar levels normal, by helping the body re-
lease its own insulin after food intake.
Trulicity (dulaglutide) comes in an easy to use, single-dose pen that does not
require mixing or measuring and can be administered at any time of the day,
independent of meals.
“Diabetes is a big burden on the healthcare
system in India. Millions of Indians live
with diabetes and have diverse needs”,said
Edgard Olaizola, Managing Director, Lilly
India.
He added, “Trulicity is an important addi-
tion to our diabetes portfolio in India and this
launch is an important milestone in our jour-
ney to help a large number of patients and
their caregivers.

BioNews
TR-Pharm, Dr
Reddy’s announce
collaboration
Dr Reddy’s Laboratories and TR-
Pharm announced a strategic col-
laboration agreement involving 3
biosimilar products. A total of three
products will be registered and sub-
sequently commercialized as a part
of this agreement by TR-Pharm in
Turkey. TR-Pharm will also manu-
facture the drug substance and drug
product upon completion of its facil-
ity investment.
Mr Mehmet Göker, general manager
of TR-Pharm, said, “Biosimilars are
a key component of our investment
strategy in Turkey to establish bio-
technological API production for
national use and regional exports.
This agreement will not only enable
more affordable medication but also
support our research and develop-
ment initiatives by building expertise
within the country. We are pleased
to have already started laying out the
groundwork for manufacturing with
Dr Reddy’s for high quality biosimi-
lar products.”
Mr M V Ramana, executive vice-
president and head branded markets
(India and Emerging countries), said,
“Turkey is a key emerging market
and we are pleased to partner with
TR-Pharm to ensure that patients in
the region get access to our portfolio
of high quality biosimilar products.
Dr Reddy’s Laboratories is and re-
mains committed to providing access
to affordable and innovative drugs to
populations around the world, and
this partnership will make this hap-
pen in Turkey.”
The partnership will also enable Dr
Reddy’s to widen the global footprint
of its biosimilar business.
3D-printed ‘Sneezeometer’
to help asthma patients
India has an estimated 15-20 million asthmatics with up to 15% of 5-11
year olds suffering the disease.
Research undertaken at the University of Surrey, UK, has led to the devel-
opment of the world’s first ‘sneezeometer’, an airflow sensor or ‘spirom-
eter’ that is sensitive enough to measure the speed of a sneeze.
For use in helping to diagnose a variety of respiratory conditions, the
sneezeometer is twice as fast, and more sensitive than any other available
device.
Spirometers measure lung capacity and are used widely to diagnose a vari-
ety of chronic and acute respiratory conditions including asthma, Obstruc-
tive Sleep Apnoea and Hypopnoea.
However, current devices are expensive, cumbersome and lack the sensi-
tivity required in difficult diagnostic situations, such as neonatal care. An
ultra-sensitive spirometer, Surrey’s sneezeometer measures the flow rate
of air through a patient’s lungs.
MSF challenge to Pfizer’s patent
on pneumonia vaccine
Médecins Sans Frontières/Doc-
tors Without Borders (MSF) has
filed a ‘patent opposition’ in In-
dia to prevent US pharmaceuti-
cal company Pfizer from getting a
patent on the pneumococcal con-
jugate vaccine (PCV13), so more
affordable versions can become
available to developing countries
and humanitarian organizations.
This is the first time a vaccine (biosimilar) patent has been challenged in
India by a medical organization,with the goal of millions more children
being protected against deadly pneumonia.
Pneumonia is the leading cause of childhood death,killing almost one mil-
lion children each year.
Currently, pharmaceutical companies Pfizer and GlaxoSmithKline (GSK)
are the only two manufacturers of the vaccine, which could prevent a large
number of these deaths.
Pfizer has priced PCV13 (marketed as Prevenar) out of reach of many de-
veloping countries and humanitarian organizations.

BioTalk
QE Prize
winner
Dr Langer
shares his
success
Dr Robert Langer
Winner of Queen Elizabeth Prize of Engineering
2015, David H Koch Institute Professor, Massa-
chusetts Institute of Technology (MIT), USA
D
r Robert Samuel Langer was awarded
the 2015 Queen Elizabeth Prize (QE-
Prize) for Engineering in February 2015
at the Royal Academy of Engineering,
London, UK. He is a world-renowned
American scientist, engineer, inventor
and entrepreneur, and David H Koch Institute Professor
at the Massachusetts Institute of Technology (MIT), USA.
The Queen Elizabeth Prize for Engineering is considered
as the highest international accolade for engineering, and
recognizes ground-breaking global innovation to inspire
next-gen engineers.
The award is a global £1 million prize celebrating pio-
neering innovations that has had a profound benefit to
humanity globally.
Dr Langer lab’s work is at the interface of biotechnology
and material science. His lab’s major focus is in studying
and development of polymers to deliver drugs, particu-
larly genetically-engineered proteins, DNA and RNAi,
continuously at controlled rates for prolonged periods of
time.
Dr Langer exclusively spoke to BioSpectrum, where he
shared his passion, origins, memories of his childhood
laboratory, entrepreneurial tips and his award-winning
work on controlled-release drug systems. Excerpts:
Q Firstly, a hearty congratulations Dr
Langer. Tell us about your award-winning
BioTalk

Dr. Andreas Castan will discuss the upstream seed train and will show how a process
intensification strategy can be used to compress timelines and decrease the cost for
this unit operation.
Vaccine Manufacturing with Single-UseTechnology:
An Evaluation of Process Economy
Dr. Mats Lundgren will share his insights on how to improve process economy
and enhance end-product quality through the implementation of single-use
technologies and novel microcarrier formats.
Unlocking the Potential for Efficiency in
Downstream Bioprocesses
Madhu Raghunathan will walk you through several innovative strategies for
achieving increased efficiency in buffer handling, chromatography unit operations,
and downstream processing in general.
Single-UseTechnology and Sustainability:
Quantifying the Environmental Impact
Bill Flanagan will talk about sustainability and how this relates to single-use
technologies in biomanufacturing operations. He will present new data on the
implications of a single-use strategy from a sustainability perspective.
Thedifferencebetween
agoodandagreatdecision
canhaveextensive
implicationsforthe
futureofacompany.
The biopharmaceutical industry has developed into a multi-billion
dollar market in just 30 years. Making decisions and setting up strategies
in a rapidly changing environment can be challenging. The difference
between a good and a great decision can have extensive implications for
the future of a company. In this environment, knowledge and experience
are what make the difference. Good insights about, for example, technical
advancements, process economy implications, and sustainability aspects
can help improve the individual decisions and strengthen the overall
business strategy.
Webinar 1
Upstream
Apr. 20, 2016
In this webinar series, four renowned subject
matter experts will share their insights into four
areas of bioprocessing: UPSTREAM, VACCINES,
DOWNSTREAM, AND SINGLE-USE TECHNOLOGY.
We will present tangible, recently developed
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Bioprocess
InsightsWebinars
Webinar 2
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Webinar 3
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Single-Use
Register to the webinars by scanning the QR code. For any queries, please write to us at supportdesk.india@ge.com
How to Improve Productivity and Process Economy
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BioTalk
work to our Indian readers, and the impact of
your controlled-release drug systems.
A
Thank you. I think engineering is such a wonderful
way to contribute to society. The two things that
give me the greatest satisfaction are discovering
principles or making inventions that enable people to
have happier and healthier lives, and seeing the people
who train in our lab succeed to become future leaders in
engineering themselves.
There are times when drugs administered to patients
could react after being in the system for more than the
required period of time or they might be ineffective by
disappearing quickly. To tackle this, controlled drug re-
lease helps maintain and sustain the drug release at an
effective level for the suitable period of time. The polymer
which was invented through my study helps in controlled
dissemination of the drug molecules. My work which won
the QEPrize is on engineered polymers which control the
delivery of large molecular weight drugs for the treatment
of diseases such as cancer and mental illness. It is already
being used in various countries, including India.
I am thrilled to be the recipient of the Queen Elizabeth
Prize 2015. The prize celebrates ground-breaking innova-
tions in engineering and in addition strives to celebrate
stories of engineering successes, raising the international
public profile of engineering and inspiring new genera-
tions of engineers to take up the challenges of the future.
Q
What sparked you to become a scientist?
A
Some of it started as a child having chemistry, mi-
croscope and erector sets. My dad also played a lot
of math games with me. All this contributed to my
liking science and math.
Q Shed some light about the lab in your
home’s basement in Albany.
A
It was a small basement and I had a Gilbert chemis-
try set. I put all the chemicals down there and I
loved doing experiments where I would make
things like rubber and make solutions change colors via
chemical reactions.
Q You have a background in Chemical
Engineering. What made you to shift
towards Biomedical Engineering?
A
I always wanted to learn biology. My PhD thesis
was on the enzymatic regeneration of ATP. I did my
postdoc in a surgery lab at Boston’s children’s hos-
pital. I was the only engineer in the hospital. It really gave
For young people, I’d say dream
big dreams, dreams that can
change the world and make it a
better place
me all kinds of ideas as to how chemical engineering
could be applied to medicine.
Q You have been researching since the 70s.
How difficult or hard has it been for you to
achieve what you have achieved today?
A
Very difficult. My first nine research grants were
turned down largely because my research went
against conventional wisdom. No chemical engi-
neering department would hire me as a professor. And I
ended up joining a nutrition department. The year after I
joined, the department head who hired me left. So the as-
sociate department heads decided to give me advice. They
told me to start looking for another job. Time helped me
overcome some of these issues as we proved that conven-
tional wisdom was incorrect. And I just never gave up.
Q You have over 1,000 patents to your credit.
How will you define innovation?
A
A new idea or invention, and its implementation
into real life
Q
You are also an entrepreneur too. What do
you have to say to all the scientists who want to
be an entrepreneur?
A: I think it’s an attractive career path but not the only
career path. Personally I love it because it enables myself
and my students to take our ideas into the real world and
help people. But science leads to many good career paths.
Q What are the common mistakes committed
by scientists while they pursue their
entrepreneurial dreams?
A
Starting a company too early. Not having good in-
tellectual property (IPs).
Q What do you advice students who hesitate
to become a scientist or pursue a research-
oriented career?
A I think that’s okay. Everyone should get lots of ad-
vice. But they should follow their passion. I think
people should do things that make them happy.
And they shouldn’t do things just to make money. BS
Raj Gunashekar

Latest
BioSupplier
Technologies
CoverStory
The invention of the microscope is one of the most
important scientific development. Since, then the
development in the laboratory instruments and
technologies have grown leaps and bounds. The
Human Genome Project to sequence the human
took 13 long years. Today, it is possible to
sequence DNA in a couple of hours.
As the research and development in the
biosciences grows, so is the demand for more
sophisticated technologies, instruments that are
affordable, precise and timely.
In the ensuing pages, BioSpectrum is publishing
a selection of open invitation articles by the
industry captains, highlighting the latest BioSupplier
technologies/products that are enabling the
biosciences industry on the course of drug discovery.

CoverStory
Are you ready
for laboratory
transformation?
Mr Amit Manjure
Head-Clinical Marketing, Laboratory Diagnostics,
Siemens Healthcare, India
The influence
of diagnostic
tests on clinical
decisions is very
high. The global in
vitro diagnostics
market is estimated
to reach $75.1 billion
by 2020 R
ising populations
in emerging econ-
omies will lead to
increased demand
for medical de-
vices, diagnostic
equipment and pharmaceuticals
in the near future.At the same
time,this demand will leverage
technological advances.In vitro
diagnostics (IVD) is one such in-
dustry that is witnessing prolifera-
tion of technology in terms of new
assays, workflow excellence, turn-
around time, etc.
IVD plays an integral role in health-
care and disease management.
The influence of diagnostic tests
on clinical decisions is very high
– almost 75% of clinical decisions
are based on a diagnostic test.The
global in vitro diagnostics market is
estimated to reach $75.1 billion by
2020, growing at a CAGR of 5.8%.
The Indian IVD industry, still in the
inception stage is valued at more
than $500 million and is expected
to surpass $1.5 billion by 2018.
Growth Drivers for IVD
With a population of more than
1 billion, India is world’s second
largest country and therefore a sig-
nificantmarket to the healthcare
providers.The demographic change
has led to growth in tier 2 and tier
3cities creating disposable income
ultimately leading to a change in
lifestyle patterns and an increase in
the lifestyle diseases like cardiovas-
cular diseases, lung disease, cancer,
obesity, diabetes, etc. One in four
Indians is at a risk of non-commu-
nicable lifestyle disease.
Accurate and quick diagnosis of
diseases has thus become a crucial
factor in providing quality patient
care.
Turn-around time (TAT)
The diagnostics labs operate in a
dynamic environment.In addition
to the accurate diagnosis, reduced
turnaround time (TAT), consistent
delivery and affordability have be-
come the need of the hour. Turn-

CoverStory
around time is the most noteworthy
manifestation of laboratory service
and a crucial barometer of laboratory
performance.As a result, laboratories
of all sizes are adapting total automa-
tion across pre-analytical, analytical
and post-analytical processes inte-
grated with information technology
(IT) since information systems are
a key differentiator among major
healthcare providers.
The innovations and discoveries in
the IVD market are transforming the
healthcare arena.The IVD market in-
cludes a variety of advanced and cut-
ting edge technologies to project the
disease state, choose the right treat-
ment and monitor thepatientsresponse
to the treatment.Anarray of assay ca-
ters to wide spectrum of diseases.
Automation, a unified solution de-
veloped expressly for the changing
workload and expanding needs of
today’s clinical laboratory, isplaying
a key role in the entire diagnostics set
up.It provides unlimited potential for
lab optimization by combining peak
performance, adaptability, and intel-
ligent technology.However,the chal-
lenges of implementing lab automa-
tion can be formidable.It is a complex
undertaking to meet business objec-
tives and clinical requirements while
managing logistics,timelines, people
and technology to achieve workflow
excellence. And the operations must
continue uninterrupted during this
transition!
The work in any laboratory is typi-
cally broken in three phases.
1. The pre-analyticalphase:this com-
prises of patient sample identifica-
tion, test request registration and
billing, sample collection, labeling
by barcode, separation followed
by transport and sample
processing.
2. The analytical phase:this com-
prises of properly calibrating the
instruments,the quality control
process and analysis of samples.
3. The post-analytical phase:This
includes all the processes that
follow the testing of the samples.
Namely, the validation of test re-
sults, transcription of results into
the records, printing and dispatch
of the results.Also, the data so
generated needs to be stored.The
samples also need to be stored
for specified period of time for
repeats or add-ons.
With this background, it is critical for
laboratories to optimize the follow-
ing flow across these three phases.
 The sample flow has to do with
the collection of the samples, to
sorting, transportation until their
disposal and/or they are sent out.
 The data (information) flow goes
from order entry to receiving or
accessing, quality control, etc. all
the way to validation, reporting
and billing.
 The material flowincludes inven-
tory tracking; invoicing and pay-
ment etc.
Removal of non value-added steps
such as reducing sample touch
points,manual bench sorting aliquot-
ing transportation, sample rerun,
results review is a key to achieving
workflow excellence.
Automation – the way
ahead!
Statistics indicate that there has
been an approximately 25 percent
H DX APTIO IOM BACK H DX APTIO WTUBES

CoverStory
increase in laboratory tests due to
screening and follow up for lipid pro-
file, blood glucose levels, glycosylated
haemoglobin, speciality tests for thy-
roid hormone levels, vitamin levels,
infectious serology and basic cancer
markers.
The diagnostics and pathological lab
test market has the potential to grow
at a CAGR of 18.9 percent.
With automation,labs of all sizes can
transform their operations to harness
change and drive maximum perfor-
mance and efficiency.Laboratories
can also customize their automation
solutionsbyidentifying the sustainable
workflows.Labs can consolidate mul-
tidiscipline testing into a single, fully
automated solution or improve spatial
efficiency,tube utilization, or resource
allocation. Siemens has helped diag-
nostic laboratories leverage the ben-
efits of automation and information
technology since 1998—making work-
flow more efficient and flexible while
improving turnaround times, reduc-
ing errors, and cutting costs.
Laboratory automation allows for
a broader diagnostic scope and in-
creased accuracy.Ultimately, labora-
tories will be able to perform more
tests in-house and reduce their de-
pendency on outsourcing services in
addition to the decrease in number
of duplicative laboratory process and
increase in throughput.
This will also allow staff to be better
utilized beyond bench testing and
routine operation including but not
limited to patient interaction,finance,
marketing services and strategic
planning002E. BS
Statistics indicate
that there has been
an approximately 25
percent increase in
laboratory tests due to
screening and follow up
facebook.com/BioSpectrumMagazine bit.ly/BS-LinkedInhttps://twitter.com/BioSpectrumMag

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CoverStory
CRISPR-Cas9
genome editing
– simple genome
editing starts here
Namritha Ravinder
Senior RD Manager, Synthetic biology, Thermo FisherScientific
The new
GeneArt CRISPR
Search Design
tool allows scientists
to search a database
of 600,000 pre-
designed CRISPR
gRNAs in human and
mouse genes
I
ntroducing the only com-
plete genome editing so-
lution designed to expe-
dite your research. Our
easy-to-use,optimized an-
dvalidated solutions span
theentire cell engineering work-
flow, making genome editing ac-
cessible to anyone at any level.We
are continuing to expand our suite
of genome editing products to span
the entire cell engineering work-
flow, from cell culture reagents,
delivery reagents and sample prep-
aration to genome modification,
detection and analysis of known
genetic variants. We offer our
state-of-the-art online CRISPR
search and design tool along with
CRISPR-Cas9 in four formats: an
all-in-one expression vector, Cas9
mRNA, Cas9 protein, and CRISPR
libraries services paired with the
optimal cell culture reagents, de-
livery method, and analysis tools
based on required application and
cell type (Figure1).
Optimal CRISPR design at
the touch of afinger
The new GeneArt CRISPR Search
Design tool allows scientists to
search a database of 600,000 pre-
designed CRISPR gRNAs in human
and mouse genes or analyze their
sequence of interest for de novo
gRNA designs using Thermo Fish-
er’s proprietary algorithms. The
tool is designed to analyze genes of
interest, identify gRNA sequences
adjacent to protospacer adjacent
motif (PAM) sites, and rank order
resulting gRNAs based on potential
off-target effects.Up to 25 gRNA
sequences per gene are provided
with recommendations based on
potential off-target effects for each
CRISPR sequence.
Invitrogen GeneArt Platinum Cas9
Nuclease is wild type Cas9 in pro-
tein form for genome editing with
CRISPR-Cas9 technology. Cas9
protein and guide RNA (gRNA)

CoverStory
NamrithaRavinderisaseniorRDmanageratThermoFisherScientificinCarlsbad,California.Sheleads
product development activities within the Synthetic Biology and Sample Prep team, with primary focus
onbuildingproducts,screeningtoolsandworkflowsforgenomeeditingandcellengineeringapplications.
Priortohercurrentrole, she was a technical lead for a wide variety of synthetic biology custom service
offerings including cDNA library generation; high-throughput gene expression and miRNA profiling
for biomarker discovery; lentivirus production; and next-generation sequencing libraries. She did her
postdoctoral research at Children’s hospital in Los Angeles in HIV virology and doctoral research in
plant molecular biology and biotechnology at University of Alabama inHuntsville.
BRIEF PROFILENAMRITHA RAVINDER
form a very stable ribonucleo pro-
tein (RNP) complex that provides
the next level of cleavage efficien-
cy over CRISPR-Cas9 vector and
mRNA-based systems when paired
with Invitrogen Lipofectamine CRIS-
PRMAX Cas9 Transfection Reagent.
The Cas9 RNP complex can act im-
mediately after it enters the cell,
since transcription and translation
are not required (Figure 2). More-
over, the complex is rapidly cleared
from the cell, minimizing the chance
for off-target cleavage events when
compared to vector-based systems.
GeneArt Platinum Cas9 Nuclease
is the recombinant Streptococcus
pyogenes Cas9 (wt) protein purified
from E.coli that can be used for ge-
nome editing with CRISPR technol-
ogy. Features and benefits include:
 Two availableconcentrations
 1µg/µL(B25640)foruseinstandard
editingscenarios,includingcellline
ssuchas HEK293 orHCT116
 3 µg/µL (B25641) for optimiza-
tion of editing conditions in
more difficultscenarios such as in
primary or embryonic cell lines,
or when screening multiple gRNA
sequences at atime
 Streamlinedcell engineering by
eliminating transcription and
translation in thecell
 Elimination of time-consuming
cloningsteps
 Minimization off-target cleav-
age due to rapid clearance of the
protein complex fromthe cell
The GeneArt Precision gRNA Synthe-
sis Kit is a complete system for rapid
synthesis of guide RNA (gRNA),
ready to complex with GeneArt Plati-
num Cas9 Nuclease for transfection-
ready Cas9 protein/gRNA ribonu-
cleoprotein (Cas9 RNP). Features
and benefits include:
 Fast assembly and synthesis of
any gRNA target in as little as
four hours, including template
assembly
 High yield (10 µg) and concen-
tration ( 200 ng/µL) ofgRNA
The Lipofectamine CRISPRMAX
Cas9 Transfection Reagent is the first
optimized lipid nanoparticle trans-
fection reagent for CRISPR-Cas9
protein delivery, providing the cleav-
age efficiency of electroporation with
the simplicity and scalability of a re-
agent. Lipofectamine CRISPRMAX
transfection reagent is an idealal
THE PERFECTPAIRING
We have paired the CRISPR-Cas9 format and delivery method for scientists to ensure the
highestefficiencies.

CoverStory
ternative to electroporation as it is
gentleron cells and more cost effec-
tive overall (Figure 3). Features and
benefits include:
 Demonstrated cleavage efficiency
tested in more than 20 cell types
including iPSC, mESC, N2A,
CHO, A549, HCT116, HeLa,
HEK293, and several others
 Low cell toxicity—fewer cells
needed to initiate your experi-
ment
 Cost savings—including both cost-
per-reaction and initial invest-
ment
 Easy scalability—an ideal deliv-
ery solution for high-throughput
experiments
Advances in genome modulation and
editing have the potential to change
the way we create energy, produce
food, optimize industrial processing,
and detect, prevent, and cure diseas-
es — improving the human condition
and the world around us. Thermo
Fisher’s trusted products harness the
power of science to transform lives.
Its instruments, routine tools, and
services offer high-quality, innova-
tive life science solutions for every-
lab. BS
WORKFLOW
Advances in genome
moudulation and
editing have the
potential to change the
way we create energy,
produce food, oprtimize
industrial processing,
and cure diseases

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CoverStory
CRISPR–Cas9:
a new hope for drug discovery
Dr Ceri Wiggins
Team Leader, Horizon Discovery
Thought to
be devoid of
the caveats
associated with
siRNA and shRNA
reagents the hope
is that novel targets
can be uncovered
T
he repurposing of
a primitive adap-
tive immune re-
sponse in bacteria,
known as CRISPR
(clustered regularly
interspaced short palindromic re-
peat), has revolutionized gene edit-
ing and provides a new and power-
ful tool to interrogate gene function
on a genome-wide level. Indeed,
the contribution of this technology
to drug discovery looks, from our
current vantage point, to be sub-
stantial. The application CRISPR–
Cas9 technology to whole genome
screening is transforming our abil-
ity to perform target identification
experiments and to understand
complex biological processes, such
as drug resistance. Thought to be
devoid of the caveats associated
with siRNA and shRNA reagents,
the hope is that novel targets can be
uncovered and rigorously validated
using CRISPR–Cas9, and that a
pipeline of innovative and validat-
ed targets will enter drug discovery
programs.
Indels are crucial: CRIS-
PR–Cas9 screens make use ofshort
guide RNAs (sgRNAs) and Cas9
nuclease, two components ofthe
CRISPR machinery in bacteria. The
sgRNA, which Cas9 binds to, con-
tains a protospacer adjacent motif
(PAM) site and this enables the tar-
geting of Cas9 to the RNA:DNA hy-
brid. Once bound, the Cas9 nucle-
ase generates DNA double strand
breaks precisely 3 base pairs away
from the PAM site. These double
strand breaks are repaired by non-
Dr Steffen Lawo
Senior Scientist, Horizon Discovery
Narinder Singh
commercial contact, Country
Head-India-Horizon Discovery.

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CoverStory
Ceri Wiggins is a Team
Leader at Horizon Discovery,
currently responsible for
the internal synthetic lethal
CRISPR screening and target
identification/validation team.
Steffen Lawo joined Horizon
Discovery GroupasSenior Scientist
in 2013.
As Country Head at Horizon
Discovery, Narinder is responsible
for business development of
Horizon’s product and service
portfolioacross India and Middle
East.
BRIEF PROFILE BRIEF PROFILE BRIEF PROFILE
DR CERI WIGGINS DR STEFFEN LAWO NARINDER SINGH
homologous end joining (NHEJ),
which frequently results in small nu-
cleotide insertions and or deletions
(indels) that can lead to the inter-
ruption of the normal reading frame,
thereby disrupting gene function.
Pooling resources: Using
lentiviral transduction to deliver both
the Cas9 nuclease and sgRNAs into
cells, Horizon Discovery has adapted
a pool-based screening protocol to
examine the effect on cell survival of
knocking out thousands of individual
genes. The sgRNAs are designed to
direct Cas9 to exons at the start of
the open reading frame, such that
any out-of-frame indels will result in
gene disruption. The screen analysis
is based on data from cells collected
at the start of the screen (3–5 days
after transduction) compared with
cells collected at the end of a screen
that have been exposed to a drug of
interest, for example. The next gen-
eration sequencing (NGS) data from
the initial time point acts as a com-
parator for the NGS data collected
at the end of the screen, such that
sgRNA loss and gain over the time of
the screen can be established. We use
a dedicated CRISPR–Cas9 screening
analysis platform, adapted from the
MAGeCK workflow (Li et al., 2014),
which enables individual sgRNAs
and gene hits to be ranked.
Resistance discovery
ahead of the clinic
Many of the initial screens that Ho-
rizon Discovery has undertaken for
a number of clients from the phar-
maceutical industry have examined
mechanisms of drug sensitivity and
resistance. Indeed, for our initial
proof of concept studies we, like oth-
ers, examined mechanisms of resis-
tance to vemurafenib, a drug that
targets the BRAFV600E activating
mutation. The GeCKOv2 genome
wide library, which contains 6 guide
RNAs against 19,050 genes (San-
janaet al., 2014), was transduced into
BRAFV600EmutantA375melanoma
cells and the cells were treated with
vemurafenib. A comparison of the
abundance of each guide RNA at the
start and end of the screen was used
to assess whether drop out or enrich-
ment of guide RNAs had occurred
over the course of the screen. Over
228 guides were shown to be 100-
fold enriched, with several sgRNAs
targeting the same genes. Using our
analysis platform, the highest rank-
ing targeted genes (MED12, NF1,
CUL3, NF2, TADA2B and TADA1)
were those whose loss is known to
confer resistance. These findings
repeated previously published data
(Shalemet al., 2013, Huang et al.,
2012, Whittaker et al., 2013).
Interestingly, when the sgRNAs for
each of these hits were evaluated
individually, it was clear that not all
guides performed equally well in the
screen. This emphasises that for suc-
cessful screening, the library compo-
sition and complexity are key consid-
erations.
Increasing the odds with a
haploid approach
Engineered from KBM7 fibroblasts,
eHAP cells are a fully haploid cell
line and are particularly suited to
CRISPR–Cas9 screens because there
is only one copy of any given gene to
edit. We used the eHAP cells to ex-
amine the mechanisms of resistance
to 6-thioguanine (6-TG), a purine
antimetabolite that is used in the
treatment of leukaemia. The biology
of the DNA mismatch repair (MMR)
system and factors that mediate resis-
tance to 6-TG have been extensively
studied and as such provide an ex-

CoverStory
cellent paradigm to test the power of
CRISPR–Cas9 resistance screens in
haploid cells. eHAP cells were infect-
ed with the whole genome GeCKOv2
library and were exposed to either
500 nM 6-TG or vehicle control and
maintained in culture to allow sgRNA
enrichment and depletion to occur.As
expected, NGS analysis revealed that
sgRNAs targeting MLH1, MSH2 and
MSH6, three genes that encode MMR
proteins, were enriched in the screen
(Branch et al., 1993; de Wind et al.,
1995, Abuinet al., 2000, Buermeyeret
al., 1999). To validate these targets
as 6-TG resistance factors, MLH1
and MSH6 knockout HAP1 cells were
generated using a CRISPR–Cas9 ap-
proach. These cells were able to pro-
liferate in the presence of 6-TG unlike
the parental cell line. Thus, CRISPR–
Cas9 approaches were used to both
identify the mechanisms of resistance
and to validate them.
The future looks bright
CRISPR–Cas9 is a fast moving
technology that has been embraced
across the board. As discussed above,
it has been used to successfully iden-
tify mechanisms of drug resistance
in whole genome screens, but its
applications extend further into ani-
mal model generation and genetic
therapies. Its use, particularly in hu-
mans, is the subject of much debate
that looks set to continue for years
to come. However, in terms of drug
discovery, CRISPR–Cas9 technolo-
gies look poised to replace RNAi as
a new avenue for more effective drug
discovery. Thanks to NGS, we are
starting to catalogue the plethora of
mutational changes that occur in the
genome of any cancer cell. With this
knowledge comes potential – novel
mutated genes and the proteins that
they encode, are candidates for prog-
nostic markers and/or new drug tar-
gets. With the ability to rapidly engi-
neer cells (and animal models) using
CRISPR–Cas9 technologies, the gen-
eration of robust models needed for
improved target identification and
validation promise to be attainable.
BS
The generation of
robust models needed
for improved target
identification and
validation promise to be
attainable.

CoverStory
Triumph of high
precision parallel
bioreactors over
conventional systems
D. Muruganand
PhD., Vice President – Marketing, Eppendorf India, Chennai
Scientists
and investors
are looking
forward to shorter
timeframes in
getting results
and the product of
interest launched
in the market
respectively
T
he biopharma in-
dustry is growing
steadily at a sig-
nificant pace and
so are their invest-
ments in research
and development. Investment in
biologics like vaccine, biosimilars,
novel biopharmaceuticals, cell and
gene-based therapeutic products
are seeing a never before trend.
The stakeholders, both scientists
and investors, are looking forward
to shorter timeframes in getting
results and the product of interest
launched in the market respec-
tively. As these processes involve
cell culture or microbial fermenta-
tion, the need for dedicated mini-
bioreactor systems for process de-
velopment and critical parameter
optimizations in low volume ranges
are certainly creating interest com-
pared to the conventional fermen-
ters and bioreactors. With time
being very critical, the single use
vessels are also gaining more at-
tention over autoclavable formats
among the biopharma users.
From conventional
shake flasks to parallel
bioreactors
While initial bioprocess develop-
ment involving microbial or cell
culture involves several steps like
cell line optimization,clone selec-
tion, screening for media and feed
components along with other pro-
cess conditions,conventional shake
flasks arestill used foroptimizing
these early steps. Though widely
used, shake flask formats onlyal-
low identifying temperature, am-
bientgas mix and agitation rates-
but poselimitation upon reaching
scalable levels with respect to the
industry standard monitoring and
control requirements. Critical pro-
cess parameters like pH, dissolved

CoverStory
oxygen (DO), gas flow rates and feed
schedules of media components are
beyond the capabilities of shake flask
format.Moreover equipment used
for screening or optimization in the
earlier steps should mimic the physi-
cal and mechanical characteristics
of productionscale reactors to the
greatest degree possible,toensure
consistency throughout development
phases.Theparallel bioreactor system
provides all essential features in a
compact and comprehensive design
with flexibility to optimize and un-
derstand parameters that influence
growth kinetics, productivity, prod-
uct quality and stability.
Parallel bioreactors over
the micro/mini bioreactor
Though micro and mini bioreac-
tor systems address the basic needs
of media selection and optimiza-
tions they still do not support when
it comes to scalable proportions
and concerns over unconventional
formats are not uncommon.Lower-
volumeby itself seems to limit for
applications where the processes
requirements are not flexible.Feed
rates, sampling volumes to mention
a few could be mandatory in these
critical steps of characterization or
optimization.Hence selection of an
ideal system for lower volumes is no
different from the standard volumes
when it comes to the expectations of
the process outcome.
Expectations in a parallel
bioreactor system
With more manufacturers getting in-
tothis spaceexpectations also grow-
from the user end.Hence the demand
for compact, comprehensive and
flexible system to adapt to present
and future needs is on the cards.
While deciding the number of vessels
the primary requirement starts with
a compact and less space occupy-
ing system.But when coming to the
process needs features like flexibility
for upgrades to enhance or extend
the configuration to meet evolving
needs,minimum level of scalability in
working volumes to establish proof
of concepts, possibility for seamless
integration to downstream equip-
mentare certainly the priorities.
Above all a simple and user friendly
supervisory control and data acqui-
sition (SCADA) software convenient
for data acquisition, monitoring and
processing becomes mandatory.
Parallel bioreactors from
Eppendorf
DASGIPparallel bioreactor systems
for microbial or cell culture applica-
tions from Eppendorfcombinethead-
vantages of small working volumes
with the full functionality of indus-
trial bioreactors.The modular design
allows expanding the system capa-
bilities in 4,8,12 or 16 parallel vessels
format controlled by single operating
system.The vessels are the industry
standard stirred tank reactors with
different workings volumes ranging
from 60 mL to 3.8 L.
The modular system provides the
flexibility to configure to the needs
of user with respect to number of
pumps, gases and their flow rates.
The availability of single use vessels
of different volumes have provided
users the flexibility to choose be-
tween autoclavable and single use
vessels in both microbial and cell cul-
ture applications.
DASBOXparallel mini bioreactor sys-
tem for microbial or cell culture has
the option to use a dedicated vessel
volume with working volume rang-
ing from 60-250 mL. These systems
are also designed to operate in mod-
ules of 4, 8, 12 or more vessels.With
both autoclavable and single use ves-
sel formats available,the user has the
choice to select.Availability of Photo-
synthetic light module can make it a
convenient choice for users working
either with plant cells or for biofuel.
Both DASGIPandDASBOXsystems
can be calibrated in parallel for
pumps and sensors making the ves-
sels perform as replicates.Though
designed for parallel reactions, these
can also be controlled independently
for maintaining completely different
parameters.
DASGIPcontrol software allows par-
allel monitoring,data capture with
online analysis options. Combined
with other software options, the
system can be integrated with third
party equipment like metabolite ana-
lyzer, Raman spectrometer etc. The
DAS ware software platform pro-
vides larger integration and analysis
flexibilities like Design of Experi-
ment (DoE), remote monitoring and
controlling, communicating with
third party OPC compliant systems
and more. BS
PARALLEL BIOREACTOR SYSTEMS

CoverStory
Single use micro
scale bioreactor
enables higher
productivity
Dr Barney Zoro
ambr 15 Product Manager, Sartorius-Stedim Biotech, Royston, UK
A strategy
for reducing
manufacturing
COGs is to use
advanced automated
micro and mini
bioreactor models to
improve upstream
cell culture
productivity W
o r l d w i d e
sales of bio-
logic drugs,
including
monoclonal
antibodies
(mAbs), fusion proteins and thera-
peutic enzymes now exceeds $120
billion per year. These therapies
cost more than small molecules,
in part because they are more ex-
pensive to manufacture. A strategy
for reducing manufacturing COGs
(cost of goods) is to use advanced
automated micro and mini biore-
actor models to improve upstream
cell culture productivity by select-
ing better clones and enabling more
efficient optimisation of media, feed
and culture conditions.
Traditionally, cell culture develop-
ment for bioprocessing begins with
screening to find clones that express
the most protein. This is usually per-
formed in small volumes of 0.1mL
to 6mL using a multiwell plate for-
mat. Because of the need to conduct
large numbers of experiments this
has resulted in the development of
systems based on 24 well single-
use multiwell plate. These have the
advantage of being quick and easy
to set up and use and because the
multiwell plate are pre-sterilised
there is no pre-process preparation
and as they are single-use there is
no post-run cleaning. Some of these
multiwell plate systems do provide
monitoring and some control of
dissolved oxygen (DO) and pH but
have the drawback that they do not
mimic the sparging or stirring ac-
tion of a large scale bioreactor as
they rely on shaking for mixing. Ad-
ditionally, they do not provide auto-
mated feeding and have a working
volume of less than 6mL, which lim-
its the amount of analytical testing
possible.
Clone selection and early process
development to identify the most
productive clones and define op-

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CoverStory
timal media or culture conditions is
typically performed in shake flasks
with two or three top clones carried
forward for evaluation in bench top
bioreactors. Using shake flasks and
bench top bioreactors is very labour
intensive and as they are generally
made of glass, require time consum-
ing pre and post-process cleaning
and sterilisation for every experi-
mental run.
Shake flasks provide no active control
of pH and DO, relying on the buffer-
ing capacity of the media and the gas
environment of the incubator. The
mixing environment is unlike that in a
bioreactor as there is no impeller. Ad-
ditionally, shake flasks are often ma-
nipulated by hand, making it difficult
to perform nutrient feeding or sam-
pling without introducing variability.
Hence, the use of shake flasks can of-
ten result in different cell growth and
titre profiles to those seen after scale-
up in a bioreactor. Data published
in Cytology of a study at Genentech
demonstrates that when cultured in
shake flasks, Chinese Hamster Ovary
(CHO) clones expressing mAbs do
not show comparable culture perfor-
mance with those grown in 2L bench
top bioreactors.
Using bench top bioreactors does
mimic the sparging and stirring ac-
tion of a large scale bioreactor but
they require considerable amount
of time for set-up, operation and
post-experimental cleaning and ster-
ilisation. Therefore, the amount of
available resource often limits use
of bench top bioreactors requiring
that researchers have to select only
their top clones to test in this way.
This can lead to the final choice of
clone sometimes performing sub-
optimally upon scale-up, adversely
affecting yield and titre. If a larger
number of runs could be performed
during clone selection under condi-
tions which are representative of the
scale-up bioreactor environment,
then it should be possible to isolate
a better performing clone for use in
manufacturing and potentially save
thousands of dollars in manufactur-
ing COGs.
To meet the need for a single-use bio-
reactor model that provides compa-
rable mixing, gassing and sampling
parameters to be used in place of
shake flasks and bench top bioreac-
tors, the advanced micro and mini
scale bioreactor systems, ambr 15 and
ambr 250 (Sartorius-Stedim Biotech)
have been developed. These integrat-
ed systems combine 10-15mL or 100-
250mL single-use bioreactor, with an
automated liquid
handling work-
station and dedi-
cated control and
analysis soft-
ware. Critical to
the use of these
systems as bio-
reactor models
is the geometric
similarity to larg-
er bioreactors
and that their
contents are
stirred by an im-
peller and gases
can be supplied
by sparging. In addition, the software
control systems and integrated single
use sensors enable these systems to
control the culture conditions in a
similar way to large scale systems en-
suring scalability.
Each workstation maintains aseptic
conditions using a HEPPA filtered
environment (ambr 15 can be in-
stalled in a standard biological safety
cabinet and the ambr 250 includes
an integrated system) and provides
independent parallel control of either
12 or 24 (ambr 250), 24 or 48 (ambr
15) bioreactors. The workstation con-
trols the stir speed, gas supply and
temperature and also provides liquid
handling automation functions for
the bioreactors, each of which can
have its own medium, feed, inoculum
and sampling strategy. Each bioreac-
tor also incorporates sensors for real-
time measurement and bioreactor-
specific automated control of DO and
pH and set points.
A major contract research organisa-
tion (CRO) compared the timelines
for clone selection and early process
development of a mAb expressing
(CHO) clone using shake flasks and
bench top bioreactors with the auto-
mated micro bioreactor. The results
showed that with reusable shake

CoverStory
flasks and bench top bioreactors,
clone selection and early process
development took around 22 weeks,
whereas using the single-use micro
bioreactors and a confirmatory run
in a reusable bench top bioreactor
ambr15 operators examining full 96 well plate Picture
this was reduced to six weeks.
Single-use micro and mini bioreac-
tor technology can provide an ac-
curate prediction of cell growth and
protein titre achieved in bench top
bioreactors. Setting up and running
reusable shake flasks and bench top
bioreactors is manually intensive,
while the fully automated single-use
micro and mini bioreactor is more
convenient, taking much less time to
set-up and run, as well as requiring
no time consuming post run cleaning
and sterilising. Thus clone selection
and early process development can
be performed rapidly and efficiently,
increasing the number of clones that
can be evaluated by up to ten fold.
This improves the chances of select-
ing a clone with optimal growth and
protein expression. The automated
system makes it easy to implement
DoE into the work flow and the geo-
metric similarity of the platforms re-
duces the risks for scale-up to larger
single-use pilot and manufacturing
scale stirred bioreactors, reducing
time-lines and saving cost. BS

CoverStory
AcquityQDa:
Separating
beyond question
Manu Grover
Product Manager-Pharmaceutical Market, Waters India.
One of the
complicated
process in
analytical industry
was handling of
Mass detection
technologies. The
research is still on
to find the most
sensitive Mass
spectrometer or
detector.
W
hen Albert
E i n s t e i n
forged the
b e d r o c k
t h e o r y
of mod-
ern physics 100 years ago, he had
no computer,nointernet and few
homes had telephones. Yet it took
one of the most sophisticated sci-
ence tools ever built, at a cost of
hundreds of millions of dollars,
to prove an idea the scientist had
crafted with little more than paper,
a fountain pen, hard work and a
mind sharper than most. Recently
physicists announced they had de-
tected gravitational waves, hitherto
a key unproven element of Ein-
stein’s general theory of relativity.
It is not always the complicated pro-
cess work better but simple tools
and process are faster and accurate
too. Waters also with same philoso-
phy started searching for simple
answers for complicated questions.
One of the complicated process in
analytical industry was handling of
Mass detection technologies. The
research is still on, to find the most
sensitive Mass spectrometer or de-
tector. Waters thought differently
and focussed on simplifying the
usage of the Mass detector tech-
nology so that it reaches to masses
and today we have world’s smallest,
sensitive enough, very robust, and
highly user friendly Mass detector
– AcquityQDa.
The product istrulyan industry
changing technology. The idea was
to empower and enable chromatog-

CoverStory
ra-
phers
with ac-
cessible mass
data, without
the training, without the complex-
ity, without extensive compound-
specific optimisation. This is realised
through the AcquityQDa detector
which is now revolutionizing prac-
tices within laboratories in India
and globally. Within India we have
more than 20 companies using the
technology in different areas of RD,
Quality Control, Drug Discovery etc.
The vision of the AcquityQDa was
born through the unmet need of the
analytical scientists. Today many
prestigious scientists and multi-na-
tional companies are thrilled with its
impact on quality of data. The QDa
has been recognized throughout the
industry both in India and globally
garnering very positive reviews and
winning multiple awards for innova-
tion. AcquityQDa was listed as one of
the top 15 innovative products of the
year.
Increased efficiency is coming from
dramatic innovation. The result of
over 30 patented Waters innovations,
this the only mass detector that fits
on top of your instrument stack. Us-
ing less bench space and less energy
than a traditional mass spectrometer,
it fits easily within your existing lab
set up
as part of your
regular workflow. Even
most cleaning and routine mainte-
nance have been innovated away,
maximizing your uptime. This is fun-
damentally different from any expe-
rience one would have had with MS.
In any analytical development we
majorly rely on UV/PDA detector as
detector of choice and live with the
limitations of same. To have more
confidence in data, to understand
the development process better and
to resolve the complex cases of mass
balance we need to have orthogonal
analytical detectors like AcquityQDa
in our development process. The
usage of the detector ensures confi-
dence in the data and hence ‘Right
time-first time’.
The challenges in UV/PDA based
developments can be resolved using
this orthogonal detector AcquityQDa
Mass Detector, which have been pur-
posefully designed to enable analysts
to readily incorporate mass detection
within a UV/PDA chromatographic
workflow. The simplicity of this Sin-
gle Quadrapole Mass detector is such
that it can be handled easily by the
chromatographers who have no MS
training and are only UV/PDA users.
AcquityQDa has the quickest start
time, once switched on, the detector
is ready to use in less than 25 min-
utes. AcquityQDa through Empower
CDS software can enable scientists to
do tasks like peak tracking, identify-
impurities/peaks, analyze non-chro-
mophoric impurities, understand-
mass-balance related issues, perform
MS finger printing, confirm peak pu-
rity data, etc.
With recent interest of many organi-
zations in Biologics and Biopharma-
ceuticals, AcquityQDa has emerged
to be quite useful in these areas as
well. AcquityQDa enables greater
selectivity, faster – high throughput
methods, and mass confirmation for
greater certainty and productivity in
routine ‘Glycan monitoring’.
AcquityQDa is being utilized by
many organizations to monitor pep-
tides over a wide molecular weight
range. The addition of mass detec-
tion allowed scientists to monitor
and quantify peptides with greater
specificity. AcquityQDa expands the
sensitivity currently available with
optical only workflows. The addition
of AcquityQDa to existing workflows
allows scientists to selectively detect
and monitor co-elution species. And
perhaps most importantly, Acqui-
tyQDa works with both TFA and FA
based separations.
Recent publications like “HILIC-MS
Determination of Genotoxic Impu-
rity of 2-Chloro-N-(2-Chloroethyl)
Ethanamine in the Vortioxetine
Manufacturing Process” by Zentiva
(Sanofi), “Implemenation of a single
quad MS detector in high-through-
put transdermal research of plant
extracts” by University of Ghent and
‘‘A novel compact mass detection
tool for the open access (OA) envi-
ronment in drug discovery and early
development” by Merck use Acquity-
QDa technology and hence exhibiting
the potential of this simple and pow-
erful tool. BS

CoverStory
Exploring new
frontiers in
biological science
using Mass
Spectrometry
Sharad Mishra
Sr. Product Manager, life sciences mass spectrometry,
Thermo Fisher ScientificScientists and
biologists
face many
challenges in
functional biology
studies that require
the observation of
proteomes over
many time points
F
uture of bioscience
through its potential
utility in RD where
pharmaceutical in-
dustries increase in-
vestment to achieve
discovery of novel compounds.
This technology will continue to
drive high-throughput screening of
candidate molecules together with
advances in ‘omics’ technologies
(genomics, transcriptomics, pro-
teomics, metabolomics) and bio-
marker identification.Innovation
is shrinking industrial machines
and medical devices to the scale of
atoms and molecules. Mass spec-
trometry is one of the important
and versatile tools that will drive
the
Mass Spectrometry is used in in-
dustrial and academic fields for
both routine and research purpos-
es. Today, there is no single area of
experimental science where mass
spectroscopy is not being used. It is
used to understand the fundamen-
tal atomic and molecular processes
and, at the same time, those of im-
mediate relevance to events within
cells. As a technique, it helps to
control processes in chemical and
biological industries, diagnose dis-
eases, discover new drugs, protect
the environment and explore mys-
teries of nature.
Scientists and biologists face many
challenges in functional biology
studies that require the observa-
tion of proteomes over many time
points, precise spatial distribution
of proteins and different cellular

CoverStory
states. These issues translated into
the analytical challenge of perform-
ing reproducible and precise quan-
tification of a few selected biological
components in the presence of very
complex background.
One of the major challenges in pro-
teomics is the quantification of low
abundance proteins and peptides
of biological relevance such as tran-
scription factors or low stoichiometry
post translational modified proteins.
The quantification of these analytes
of interest is complicated by the very
large dynamic range observed for cel-
lular protein expression, especially in
humans. With the development of
new generations of mass spectrom-
etry platforms providing high resolu-
tion and multiple detector versatility,
new strategies are available to push
the limits of quantification.
This new technology ensures that
scientists don’t miss anything in
their area of research and provides
a strong platform, combining next-
generation screening techniques
with advanced targeted methods for
protein quantitation. It is designed
to expand researchers’ capabilities
in advanced proteomics and me-
This new technology
ensures that scientists
don’t miss anything in
their area of research
and provides a strong
platform
tabolomics applications, including
targeted, data-independent acquisi-
tion (DIA) and top-down analyses
with the industry’s highest level of
sensitivity. This delivers more com-
plete sequence coverage and allows
scientists to perform more inclusive
analyses.
On January 27, 2016, Thermo Fisher
Scientific’s Orbitrap Fusion Lumos
Tribrid Mass Spectrometer received
the SelectScience Scientists’ Choice
Award for Best New Drug Discov-
ery Product of 2015. This award cel-
ebrates the new technologies that
made the biggest impact in drug dis-
covery and development research in
2015. The awards are unique in this
industry as they empower scientists
to nominate and vote for their favor-
ite new product, allowing them to
have their say about which manufac-
turers have truly enabled their work.
We’re seeing first hand how Orbi-
trap mass spectrometry is driving the
future of bioscience, helping scien-
tists push the limits of quantitation
and protein characterization further
and faster. It is ideal for laborato-
ries that require more extensive and
more profound analytical informa-
tion from their sample, especially
lower limits of detection and better
sequence coverage when characteriz-
ing proteoforms, which was not pos-
sible with other high-resolution mass
spectrometry systems.
This technology also enables scien-
tists to:
 Confidently quantify low-level
analytes, low atomic LOQ in
nLC analysis and fg in high flow
analysis;
 Be more selective about which
instruments they perform their
MS/MS experiments on;
 Characterize intact proteins with
top down on LC time scale, which
means lower detection limits and
higher throughput; and
 Elucidate structures more thor-
oughly and easily by using any
fragmentation mode, at any stage
of MSn analysis, with detection
by either analyzer, which maxi-
mizes structural information from
metabolites, glycans, PTMs, and
sequence polymorphisms. BS

BioTalk
2016 Padma Bhushan Awardee, Dr Alla Venkata Rama Rao
Scientific
Research and
Entrepreneurship
does not go hand-in-hand
Dr Alla Venkata Rama Rao (Dr AV
Rama Rao) needs no introduction.
Rama Rao is the only Fellow of the
Indian National Science Academy
(FNA) who has trained 112 PhD
students, published more than 250
papers in reputed international
scientific journals, developed over
30 process technologies for making
life saving drugs more affordable
and finally after retiring as Director
of Indian Institute of Chemical
Technology, built a multi-million
dollar pharmaceutical company
(Avra Laboratories) that currently
has over 550 employees.
I initiated process
chemistry and
came out with a
novel process for
manufacturing
Diazepam

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BioTalk
Q
Congratulations on the
prestigious Padma
Bhushanaward. Please
describe your journey so far.
Dr AV Rama Rao: I was born and
brought up in Guntur (AP) and did
my graduation (chemistry) in 1956
from A.C. College. After working for
two years as demonstrator and tech-
nical assistant in A.C. College and
Agricultural College, Bapatla, respec-
tively, I joined Bombay University
Department of Chemical Technology
(BUDCT) in 1958 for my graduation
in Chemical Technology with special-
ization in pharmaceuticals and fine
chemicals. I continued my career as
a PhD student at National Chemical
Laboratory (NCL) under the guid-
ance of Prof. K Venkataraman, the
then Director of NCL and obtained
my degree, PhD (Tech.) in 1964.
Unlike many who go abroad to pur-
sue their post-doctoral career, I fol-
lowed Prof. Venkataraman’s advice
to stay at NCL and worked on the
structure of lac dye, an age old prob-
lem unsolved for almost 100 years.
I was offered Scientist B at NCL in
1965, without crossing the seas. For
the next 7 years, I was totally com-
mitted to academic research and be-
lieved that industrial research means
a mediocre work that was carried out
by industrial laboratories. In 1973
based on CSIR directive I initiated,
process chemistry and came out with
a novel process for manufacturing
Diazepam, an anti-anxiety agent and
used widely the world over. During
that period I met Dr Y K Hamied,
the present Chairman of Cipla, who
showed keen interest to commercial-
ize my process without wasting much
time. This was the first example of a
CSIR Technology transfer to industry
and successfully commercialized in
1973. Since then I brought the cul-
ture of institutions and industry in-
teraction and helped pharmaceutical
industries in several ways.
In 1975, I felt the need to spend two
years at Harvard University in Prof.
E J Corey’s group (Nobel Laureate
in Chemistry in 1991) to enhance my
skills in organic synthesis. This ex-
posure brought a big change in my
outlook on scientific and industrial
research. I was selected as head of
the organic chemistry division at
NCL in 1980. I established in India
for the first time a school of excel-
lence for the synthesis of bio-func-
tional molecules such as anti-tumor
antibiotics, immuno suppressants,
cyclic peptides including vancomycin
etc. I moved to Hyderabad in 1985 as
Director of RRL and transformed the
Regional Research Laboratory (RRL)
into more globally respected Indian
Institute of Chemical Technology.
I was the first Indian scientist to take
the lead in nurturing and fostering
integration in basic science, technol-
ogy development and engineering
design to provide complete package
for commercial exploitation. I was
also instrumental in pioneering the
concept of institution and industrial
interaction with several leading phar-
maceutical industries such as Cipla,
Lupin, Cadila, Dr Reddy’s, FDC etc.I
was also responsible in developing
alternative affordable technologies
for several essential drugs includ-
ing anti-HIV drugs which enabled
the Indian pharmaceutical industry
to introduce them in the market at
a fraction of the prevailing interna-
tional prices.
Q
You are one of the few
scientists entrepreneur
who have successfully
commercialized research.
What is the secret recipe of
your success?
Dr AV Rama Rao: While working
at NCL, I started working as a con-
sultant to Indian pharmaceutical in-
dustries. I had long association with
Cipla and interacted closely with Dr
Y K Hamied on various aspects on
products from the concept of iden-
tifying the compound, developing
laboratory scale suitable process
that can be adopted by the indus-
try and finally marketing the same.
This knowledge enabled me to at-
tract funds from private industries.
It is essential to have close links with
the manufacturing chemists and en-
gineers and incorporating various
parameters that go into smooth com-
mercialization. Before we undertake
lab work, I also insist on my collegues
to work out paper technology taking
into account the cost of raw material,
alternative affordable technologies
and finally transfer to industry. I al-
ways believe that the success of tech-
nology depends on many people who
are working on the shop floor and if it
fails, I used to take the entire blame
but never happened.
Most of our scientists have to learn
several lessons concerning com-
mercialization of a product such as
sourcing raw material, simple con-
cepts of scaling up the process, haz-
ards involved and safety aspects of
it etc. This is mostly lacking among
our scientists. Doing science is great
but taking it to commercialization is
not easy. I was the first academician
to realize the potential and commer-
cial opportunity in providing chemi-
cal research services (now referred
as CRAMS) to various international
pharmaceutical companies by start-
ing such programs after my retire-
ment as Director IICT. Following my
example, today there are more than
500 such companies operating in In-
dia. Avra Laboratories, the company
I founded in 1995 with no external
investment, has grown significantly
and now has over 550 employees.
Avra is the first chemical company to
receive CSIR Diamond Jubilee Tech-
nology Award for 2014 (Rs 10 lakh-
cash award to be given by the Prime
Minister of India).

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