Biotec Presentation 27 March 2012


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Biotec Presentation 27 March 2012

  1. 1. Biotec Services InternationalJohn Development Manager
  2. 2. Who are Biotec?Your company of choice for temperature controlled pharmaceutical services. Throughexperience gained from over 15 years in the clinical supply arena, Biotec haveassembled a team of dedicated professionals to ensure that every project we manage onyour 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
  3. 3. Product ExperienceClassification Product typeBiologics Monoclonal antibodies Therapeutic proteins Vaccines VirusesAdvanced Therapy Medicinal Stem cellsProducts Gene therapies (GMO Biosafety level II) Tissue engineered productsSmall molecules Oral Injectable Topical InhalationControlled drugs Schedules 2 to 4Devices Patient use Surgical use
  4. 4. QP & GMP Consultancy• Eight 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
  5. 5. 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
  6. 6. Clinical Supplies• Management of unlicensed medicines through Biotec’s Specials supply service • Manufacturer 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
  7. 7. 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
  8. 8. Global Logistics
  9. 9. GMP Temperature ControlledStorage• Proven track record of successful long term storage for biological (up to Biosafety level 2), controlled drug (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
  10. 10. Advanced Therapy MedicinalProducts• 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
  11. 11. Commercial Services• Managed through Biotec’s wholesaler Dealers licence• Dedicated team to manage commercial product storage and distribution• 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
  12. 12. The Biotec Approach….at Biotec StrategyCommunication Committed team who understand the clients needs Low staff turnover – retention of client preferences Flexible team to ensure all clients are offered a premium serviceProject Management Dedicated Project Manager assigned to each customer First point of call for queries Work in partnership to achieve project goalsExpertise Experienced management, operational and Quality teams Large proportion of repeat business from a global client base Extensive experience with difficult to handle productsForward Thinking Investment to meet client needs Focus on continuous improvement
  13. 13. Biotec Facilities (Capacity) Capacity Biotec House Bio2tec Facility size 14,000 ft2 10,000 ft2 General warehousing 86 pallets 30 pallets Controlled ambient 26 pallets 150 pallets 2-8°C 20 pallets 80 pallets plus 20,000 kits -20°C 800 kits 50 pallets 2,000 kits -80°C 340,000 vial - locations Liquid/vapour phase nitrogen 27 x 40 litre dewars