2. Vision
“By 2012, Biotec will be the market leader in cold chain pharmaceutical
services, headquartered in the UK with a global presence. We will achieve this
through a highly skilled, motivated team using best practice and technological
advances.”
Mission
We ensure that patients’ and clients’ needs are at the forefront of our business
whether the medicines are for clinical trials or everyday use.
3. Background Core Services
Founded 1997 QP & GMP Consultancy
Privately owned Clinical Supply
Purpose built facility Unlicensed medicines
Queen’s Award for Enterprise 2009 Marketed Product
Cold chain specialists Logistics
Fully licensed & inspected by MHRA Stand-alone storage
4. Biotec’s wide product experience includes:
• Biopharmaceuticals • Small molecules
Monoclonal antibodies Oral
Vaccines Injectables
Therapeutic proteins Topicals
Inhalation products
• Advance Therapy Medicinal products
Stem cells •Controlled drugs
Gene therapies (schedules 3 and 4)
Tissue Engineered product
• Devices
For patient use
For surgical use
5. QP & GMP Consultancy
• 6 QPs with wide experience • Assistance with:
of all core areas EU regulatory requirements
• Manufacturing process Label text compliance
review and development Blinding issues
• Facility development
• Batch certification
• IMPD review
• QP audits and familiarisation visits
for IMP and Marketed Product
importation
6. Protocol interpretation
for kit design and
supply strategy
Clinical Supply: Returns and destruction
IVR and IWR
controlled studies
Global distribution Product
specification file
Expiry date (PSF) set up
extension
Randomisation
schedules and
Patient Pack decode options
assembly
Primary packing Sourcing of comparators
and ancillary products
Label and leaflet
design, translation and
printing using Prisym
software
7. Unlicensed medicines
• Management of unlicensed medicines • Compassionate Use:
(treatment of patients under Continuation of treatment following
the responsibility of the physician) participation in a clinical trial
• Named Patient • Biotec can assist with:
UK “Specials” legislation, commonly Import authorisation
known as “Named Patient” Labelling and assembly
France – ATU QA release
US – expanded access Global distribution
8. Marketed Pharmaceuticals
• Biotec can assist with: • Biotec specialises in small batches
Artwork generation for niche markets
Multi language label and leaflet design,
• Low temperature
translation and printing
and difficult-to-handle products
Label and assembly
QP certification
Management of invoicing on behalf
of licence holder
9. Biotec can provide the following Logistics
services (Import and Export services)
• Fully qualified shipping systems • A range of temperature monitors to suit
for transport of product at: the specified temperatures
15 to 25ºC
• GMP storage and re-packaging
2 to 8ºC for trans-shipments
-15 to -25ºC
• Product – specific qualification of shippers
-60 to -80ºC
& transport systems to meet individual needs
-140ºC
• A range of specialist courier options
• Preparation of shipping documentation
• Depots for storage and distribution
Customs invoices
where appropriate
Shipping declarations
10. Biotec offers:
• Temperature controlled storage at • Cold rooms and freezers have
Controlled ambient (+15 to +25ºC) back-up condensers
Refrigerated (+2 to +8ºC)
• Customised non-standard storage
Frozen (-15 to -25ºC)
solutions on request
Ultra-low temp (-80ºC)
Vapour (-140ºC) or Liquid Nitrogen (-196ºC) • Available capacity
• All areas fully validated, temperature
mapped, monitored and linked
to emergency back-up
