Presentation by Alex Huyben of HALIX for the Science meets Business café of 13 Jun 2013. This event was held in the BioPartner Accelerator building in Leiden.

1. CMO Manufacturing & Services

3. We deliver GMP every day!
That is what we do at HALIX. HALIX is a Contract Manufacturing Organization
for the production of clinical batches in the biopharmaceutical industry. We
offer our customers reliable GMP manufacturing and a complete portfolio of
services.
QUALITY
Quality is our top priority. Our quality systems are embedded in all stages of
operational practise. Production is performed in our state of the art cGMP
facility. Routine release tests are performed in our well equipped QC
laboratories.
RELIABILITY
We have over 50 years experience in manufacturing and release to the
market of biopharmaceutical products.
DEVELOPMENT
Our R&D department has a proven track record of developing
diagnostics and vaccines to cure allergy diseases. After successful tech
transfers to our cGMP production plant, these products are produced,
released and delivered on a daily basis.
COMMITMENT
It is our mission to ensure your product reaches its full potential.
Our approach is based on providing a flexible development
and manufacturing package created through close interactive
partnerships with our customers.

4. Company Profile
HALIX is part of the HAL Allergy Group, a Dutch
biopharmaceutical company set up in Haarlem, the
Netherlands over 50 years ago. In 2012 HALIX was
launched as a separate business entity for contract
manufacturing.
We are proud to offer our clients reliable GMP
manufacturing in combination with a complete
portfolio of services, using an experienced
manufacturing organization for sterile vaccines. This
means that we are offering technology, services,
R&D and the human factor.
OUR MISSION STATEMENT
Provide full GMP Bio-phamaceutical services to R&D
companies and institutes, entailing manufacturing
including complex service support to facilitate
development projects up to marketing approval, at
fair prices.
OUR VISION
Position HALIX as an experienced and stable Expert
in the Bio-pharmaceutical CMO Industry, matching
services with highest quality requirements, reliability,
consistency and flexibility.

5. HAL Allergy starts HALIX
HAL ALLERGY GROUP
Founded in 1959 in Haarlem
Haarlems Allergenen Laboratorium
Part of the
Droege International Group, Germany
Relocation to BSP Leiden in 2009
Head Office – new production facilities
Biopharmaceutical company
manufacturing and supply of therapeutic
vaccines
Capabilities in
R&D, QA, QC, operations, regulatory
Driven by
commitment, partnership,
innovation
Start of contract manufacturing
2011
Launch of HALIX 2012
NETHERLANDS
HAL Allergy
Headquarter
GERMANY
HAL Allergy
GmbH
POLAND
HAL Allergy
sp. z.o.o.
SPAIN
HAL Allergy
S.L.
ITALY
HAL Allergy
s.r.l.
AUSTRIA
HAL Allergie
Handels-GmbH
NETHERLANDS
HAL Allergy
Benelux B.V.
NETHERLANDS
HALIX B.V.

6. Manufacturing site
Operational and cGMP approved since 2009
Facilities
Production facility 3,000 m2
Clean rooms grade C 650 m2
Clean rooms grade B 200 m2
BSL2 clean room grade C/B 120 m2
Utilities
HVAC manufacturing 80,000 m3
/h
HVAC Cell culture 5,000 m3
/h
Purified water production 2 m3
storage - 400 L/h
Water for injection production 2 m3
storage - 200 L/h
Clean steam generation 2.7 bar
Equipment
Single use bioreactors capacity up to 500 L
Pharma grade vial washer 2R,6R, 50ml vials
Multipurpose autoclave rain, mist, standard
process
Dry heat steriliser depyrogenising at
250 °C
Aseptic filling line up to 20,000 vials per
batch
Freeze dryer 5.2 m2
Cooled storage room 2°- 8°C 200 m2

7. Focus of HALIX
GMP manufacturing of clinical batches
Technical transfer with Clients
Development, upscaling
Manufacturing
Testing
Release
Logistics
Recombinants – antibodies – vaccines
Services Process

8. Services & Key Expertise
Analytical service
SDS-PAGE
Immunoblot
UV/VIS spectroscopy
Protein Bradford
Sterility
Bioburden
Endotoxin
Visible particles
Extractable volume
Uniformity of dosage
units
Osmolality
Regulatory support
IMPD
Dossiers
Europe
Analytical development
HPLC methods
2D Electrophoresis
ELISA
Turbidity measurements
CD
Lyophilisation
Formulation
development
Cycle development
Scale-up
Label & Pack
Randomized clinical
trials

9. Manufacturing capabilities
USP DSP FORMULATION STERILE FILLING LYOPHILIZE LABEL & PACK STORAGE &
DISTRIBUTION
BSL2 Grade Class C/B/A Pharmaceutical clean AreaClean Room Class C/B/A
Recombinant protein
production
Single use Bioreactors up
to 500 L scale
in process testing
Aseptic filling
Label design
printing
Packing for double blind
randomized trial material
Cold chain; storage and
shipping within Europe
Extraction
Purification of
crude extracts
Ultra filtration
Chromatography
Formulation
Sterile filtration
Aseptic manual
filling
Aseptic
automatic filling
Visual inspection
Freeze drying

11. Dr. P.H Flore
CEO HAL Allergy Holding
Biotechnology expert
20 years in veterinary and human vaccine field
Alex Huybens
General Manager
10 years operations experience in GMP
biopharmaceutical manufacturing
Dominique Mudde
QA/RA Director
20 years experience in biotech manufacturing and Quality
assurance
Dennis Verbart
Sr. developer
10 years experience of pharmaceutical
development and manufacturing
Marina van der Meer
CMO Plant Manager BSL2
7 years CMO experience in development,
tech transfers and GMP manufacturing of biopharmaceutical
processes
HALIX B.V.
J.H. Oortweg 15-17
2333 CH Leiden
Tel: 088-1959 000
Fax: 088-1959 001
www.halix.nl
info@halix.nl
Meet the HALIX Team

12. HALIX B.V.
J.H. Oortweg 15-17, 2333 CH Leiden
Tel: 088-1959 000 Fax: 088-1959 001
www.halix.nl