Biotec Services International: Your Company of Choice for Temperature Controlled Pharmaceutical Services
1.
2. Biotec Services International
John Shaw
john.shaw@biotec-uk.com
Business Development Manager
Paul Viggers
paul.viggers@biotec-uk.com
Business Development Manager
Sarah Coram
sarah.coram@biotec-uk.com
Business Development Manager
3. Who are Biotec?
Your company of choice for temperature controlled pharmaceutical services. Through
experience gained from over 15 years in the clinical supply arena, Biotec have
assembled a team of dedicated professionals to ensure that every project we manage on
your behalf is ‘In Safe Hands’ from initiation to completion.
Background
• Founded in 1997
• Privately owned
• Split-site, purpose built GMP facilities licensed by the MHRA
• Queen’s Award for Enterprise 2009
4. Product Experience
Classification Product type
Biologics Monoclonal antibodies
Therapeutic proteins
Vaccines
Viruses
Advanced Therapy Medicinal Stem cells
Products Gene therapies (GMO Biosafety level 2)
Tissue engineered products
Small molecules Oral
Injectable
Topical
Inhalation
Controlled drugs Schedules 2 to 4
Devices Patient use
Surgical use
5.
6.
7. QP & GMP Consultancy
• Seven QPs with wide experience of Biotec’s core service areas
• Advice to ensure speedy transition through regulatory hurdles utilizing
Biotec’s unique ‘Product Supply Route Map’
• QP audits & familiarisation visits for IMP and Marketed Product importation
providing a smooth path to release
• Expert knowledge regarding:
• EU regulatory requirements
• Label text compliance
• Blinding issues
8.
9. Clinical Supplies
• Comprehensive clinical trials supply service by combining:
• In-house capabilities and expertise
• Services of expert partners where appropriate
• Currently serve over 35 clients with one or more clinical
projects – Phase I to III
• Global supply
• Customer base spanning from West Coast USA to Asia
Pacific
• Staff adept at handling multi-national, multi-cultural
trials
10. Clinical Supplies
• Management of unlicensed medicines through Biotec’s Specials supply service
• Manufacturers Specials Licence MS/19819
• Continuation of supply to patients for compassionate use
• Biotec’s experienced Project Management team advantage
• An average of 14 years industry experience
• Extensive knowledge of handling challenging products and clinical trials
• A flexible approach to reporting activities – tailored to client requirements
• Established team who strive to develop the relationship and stay with the client
throughout future projects
11.
12. Global Logistics
• Expert logistics team take control to reduce risk to client, patient and product
• Handle shipping declarations and import/export documentation
• Site specific advice available via ‘In Safe Hands’ video and proactive
communication
• Qualified shipping systems from ambient temperature to vapour phase nitrogen
• Vast experience in handling ultra low temperature materials
• Product specific qualification of shippers & transport systems if required
• Range of temperature monitoring options available to meet specific requirements
• Utilisation of partner depot network for global supply
• 23 depots in key geographical locations
15. GMP Temperature Controlled
Storage
• Proven track record of successful long term storage for
biologicals (up to Biosafety level 2), controlled drugs
(Schedule 2 to 4), clinical and retain materials
• Flexible approach to storage offering single sample
through to pallet size options at a range of temperatures
• Dual site storage managed via one point of contact
• ‘Rapid Response Service’ - reactive to expedited
shipment requests to ensure that material is transferred
rapidly
16.
17. Advanced Therapy Medicinal
Products
• Over 10 years experience handling ATMPs
• Proven track record handling ultra low temperature
material
• Technical support team to advise on specific product
handling options
• Constant review of new technology to improve
Biotec’s service offering
18.
19. Commercial Services
• Managed through Biotec’s wholesaler Dealers licence
• Commercial supply activities segregated from clinical projects
• Strategy is to focus on niche products
• Hospital supply
• Orphan drugs
• Difficult to handle, temperature sensitive products
• Expedited dispatch and global market delivery
20. The Biotec Approach
….at Biotec Strategy
Communication Committed team who understand the clients needs
Low staff turnover – retention of client preferences
Flexible team to ensure all clients are offered a premium service
Project Management Dedicated Project Manager assigned to each customer
First point of call for queries
Work in partnership to achieve project goals
Expertise Experienced management, operational and Quality teams
Large proportion of repeat business from a global client base
Extensive experience with difficult to handle products
Forward Thinking Investment to meet client needs
Focus on continuous improvement
23. Regulatory History
• Inspected by MHRA every two years since 2004 with the
adoption of the EU clinical trials directive 2001/20/EC
• No critical or major observations during this time
• Next inspection planned for May 2012
• Biotec possess the following licences
• MIA 19819
• MIA(IMP) 19819
• Manufacturers Specials Licence MS/19819
• Also inspected annually by BMTRADA for verification of
compliance to ISO9001:2008
• Regular client audits averaging two per month
24. Clinical Supplies
• Protocol interpretation for kit design and supply strategy
• IVR and IWR controlled studies
• Randomisation schedules and decode options
• Sourcing of comparators and ancillary products
• Label and leaflet design, translation and printing
• Primary packing
• Patient Pack assembly
• Global distribution
• Expiry date extension
• Returns, reconciliation and destruction
25. Global Logistics
• Shipment temperatures supported
• +15ºC to +25ºC
• +2ºC to +8ºC
• -15ºC to -25ºC
• -60ºC to -80ºC
• -140ºC (dry shipper)
26. GMP Temperature Controlled
Storage
• Storage temperatures supported
• +15ºC to +25ºC
• +2ºC to +8ºC
• -15ºC to -25ºC
• -80ºC
• Vapour phase N2 (-140ºC)
• Liquid N2 (-196ºC)
