biotec presentation 27 march 2012
Post on 04-Aug-2015
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John Shaw
John.shaw@biotec-uk.comBusiness Development Manager
Biotec Services International
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
Product Experience
Classification Product type
Biologics Monoclonal antibodiesTherapeutic proteinsVaccinesViruses
Advanced Therapy Medicinal Products
Stem cellsGene therapies (GMO Biosafety level II)Tissue engineered products
Small molecules OralInjectableTopicalInhalation
Controlled drugs Schedules 2 to 4
Devices Patient useSurgical use
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
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
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
• 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
Global Logistics
Global Logistics
GMP Temperature Controlled Storage• 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
• 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
Advanced Therapy Medicinal Products
• 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
Commercial Services
….at Biotec Strategy
Communication Committed team who understand the clients needs Low staff turnover – retention of client preferencesFlexible team to ensure all clients are offered a premium service
Project Management
Dedicated Project Manager assigned to each customerFirst point of call for queriesWork in partnership to achieve project goals
Expertise Experienced management, operational and Quality teamsLarge proportion of repeat business from a global client base Extensive experience with difficult to handle products
Forward Thinking Investment to meet client needsFocus on continuous improvement
The Biotec Approach
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
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Liquid/vapour phase nitrogen 27 x 40 litre dewars
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