John Shawjohn.shaw@biotec-uk.comBusiness Development Manager

Paul Viggerspaul.viggers@biotec-uk.comBusiness Development Manager

Sarah Coramsarah.coram@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 ExperienceClassification Product typeBiologics Monoclonal antibodies

Therapeutic proteinsVaccinesViruses

Advanced Therapy Medicinal Products

Stem cellsGene therapies (GMO Biosafety level 2)Tissue engineered products

Small molecules OralInjectableTopicalInhalation

Controlled drugs Schedules 2 to 4Devices Patient use

Surgical use

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

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• 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

• 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 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

• 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

• 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 StrategyCommunication 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 Biotec 2

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 -

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

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

• Shipment temperatures supported• +15ºC to +25ºC• +2ºC to +8ºC• -15ºC to -25ºC• -60ºC to -80ºC• -140ºC (dry shipper)

Global Logistics

GMP Temperature Controlled Storage• Storage temperatures supported

• +15ºC to +25ºC• +2ºC to +8ºC• -15ºC to -25ºC• -80ºC• Vapour phase N2 (-140ºC)• Liquid N2 (-196ºC)