1. Copyright © 2008 | Aseptic Technologies | All rights reserved Crystal , the Closed Vial Technology A Revolution in Aseptic Filling Overall Introduction Document January 2009

2. Copyright © 2008 | Aseptic Technologies | All rights reserved New concept of Crystal ® | Process Sterilization (Gamma irradiation) Molding & Closing (Class 100/A/ISO 5) Assembly (Class 100,000/C/ISO 8) CappingLaser re-sealingFilling Filling line under barrier (Class 100/A/ISO 5) Clean & sterile “ready to fill” vial Molding site Irradiation unit Pharmaceutical site

3. Copyright © 2008 | Aseptic Technologies | All rights reserved The Crystal ® Closed Vial Technology Key advantages The Vial Body made of COC and stopper of thermoplastic elastomer: Hydrophobic material to prevent electrostatic interaction with soluble proteins Unbreakable vial Glass-like transparency Specially designed stopper minimizing loss of residual volume Exceptional inertness: low absorption, no ion and very few leachables Excellent moisture barrier Bio-compatible Ability to reduce oxygen concentration to 0.1% Crystal ® vial is particularly suitable for: High value products Toxic products

4. Copyright © 2008 | Aseptic Technologies | All rights reserved The Crystal ® Closed Vial Technology The Filling process The Crystal ® closed vial enables to: Eliminate most complex steps of aseptic filling – no WFI washing – no hot-air tunnel – no siliconization – no stoppering Limit risk of batch release thanks to process simplification Secure potent and high-value products Key advantages Crystal ® Technology drastically simplifies aseptic filling operations

5. Copyright © 2008 | Aseptic Technologies | All rights reserved Vial description Ensures sterility assurance level of the piercing area Ensures closure integrity Made of Thermoplastic Elastomer (TPE) Allows laser resealing after filling Made of Cyclo-olefin co-polymer (COC) Contains volume from 0.2 to 20ml Vials up to 50 ml are feasible Ensures mechanical stability Flip away cap Top ring Stopper Vial body Bottom ring Crystal ® vial is closed in a class 100 A room before being sterilized by gamma irradiation

6. Copyright © 2008 | Aseptic Technologies | All rights reserved Market research results Crystal ® vs. glass vial 246 healthcare professionals from hospital settings interviewed 71 doctors, 161 nurses and 14 hospital pharmacists 134 in Europe (F, B) and 110 in the US (West and East Coasts) Crystal  preferredNo preferenceGlass preferred Europe USA Doctors Nurses Pharm. Full presentation available on request 87% of professionals prefer Crystal ® In each regionBy each professional

7. Copyright © 2008 | Aseptic Technologies | All rights reserved Closed vial filling line | Description Production line 1 meter 3.28 feet Vial loading area to introduce vials provided in a sterilized box E-beam to ensure sterility of the filling site on the stopper Floating pulley to move from continuous movement to intermittent movement Laser resealing of the needle piercing trace in the stopper Vial filling done with a special needle injection through the stopper High-speed capping using snap-fit technology CVFS (Closed Vial Filling System) to ensure class 100 condition during all operations Laminar airflow

8. Copyright © 2008 | Aseptic Technologies | All rights reserved Three formats of line available Designed to fill large commercial batches Capacity: up to 600 vials/min Able to handle all formats of vials (1 to 50 ml) Equipped with 6 to 24 filling needles and lasers Space needed: 100 m² (machine footprint: 44 m²) Capacity increase is feasible by adding filling heads and lasers Production line ( Crystal  P6 to P24) Designed to fill clinical batches and small commercial batches Capacity: up to 75 vials/min Able to handle all formats of vials (1 to 50 ml) Equipped with three filling needles and lasers (C3) Space needed: 40 m² (machine footprint: 9 m²) Clinical line ( Crystal  C2 or C3) Designed to fill very small batches (<5,000 vials) Capacity: about 10 vials/min Able to handle all formats of Crystal  vials (1 to 50 ml) and glass vials Equipped with a robot performing filling, re-sealing and capping Space needed: ~8 m² (machine footprint: 1 m²) Laboratory line ( Crystal  L1)

9. Copyright © 2008 | Aseptic Technologies | All rights reserved Lyophilization in Crystal ® Process Pusher 1.Normal vial filled but not laser re- sealed 2.Penetrator (funnel shape) placed in line on vial top 3.Lyo shelve moved down to push penetrator and re-open piercing trace 4.Lyophilization done through piercing trace 5.Penetrator withdrawn and vial laser re-sealed and capped Lyo shelve Tests conducted using identical cycles compared to glass vials: Lactose 5 and 10%: successful Sucrose 5 and 10%: successful Viruses: same virus titer as in glass

10. Copyright © 2008 | Aseptic Technologies | All rights reserved Key advantages of Crystal ® Technology For your regulatory team For your supply chain team For your manufacturing team For your QA/QC team For your marketing team For your financial team For your manufacturing team For your sales team For whom? Provide a top-class sterility assurance level thanks to a closed ready to fill container Secure the products inside an unbreakable and coded container Simplify entire filling process (lean manufacturing) Quicker initial validation and less follow-up validation work Facilitate handle by healthcare specialists Reduce capital expenses Reduce operating expenses despite vials more expensive than unclean non-sterile glass vials Boost sales thanks to better perception by end-users Why? SAFER EASIER INCREASE PROFIT

11. Copyright © 2008 | Aseptic Technologies | All rights reserved The history of Aseptic Technologies 2003200420052007200620022008 Presentation of concept to FDA & EMEA 1st successful Media Fill (clinical line) 2nd successful Media Fill (production line) Presentation of validation results to FDA Contract filling line approved by EMEA at AT DMF at FDA for contract filling at AT First vial manufacturing line full scale First prototype of vial manufacturing line Creation of Aseptic Technologies First collaboration contract signed with a major CMO: NextPharma (EU, US) First production line to be delivered to GSK Biologicals (Belgium) 2009

12. Copyright © 2008 | Aseptic Technologies | All rights reserved Current status of the Crystal ® Technology Use of technology -One Production line (36,000 vials per hour) sold to GSK Biologicals for vaccine filling -Stability tests started with two vaccines from GSK Biologicals and several products from biotechs and contract manufacturers Vial -Vial made by injection molding (1 and 2 ml) available at industrial scale -Larger volumes (10 to 100 ml) made by injection blow molding -Design and feasibility pilot phase finalized -Small scale production pilot under development Line -Mechanical and pharmaceutical validation performed -Media fill simulation: no contamination in more than 100,000 vials filled Filling capabilities -Clinical line installed in our facility -Inspected by EMEA, approval granted for stability batches -Two DMF filed at FDA (both CBER and CDER) -Several partnerships with contract manufacturer, including NextPharma to fill at Aseptic Technologies for partner clients -Aseptic Technologies site elected as “Facility of the Year” by ISPE for equipment innovation

13. Copyright © 2008 | Aseptic Technologies | All rights reserved Aseptic Technologies Launched in June 2002 with a capital of 25 Mio EUR with the objective to develop the closed vial and its filling line, capital increased to 55 Mio EUR in 2005 Subsidiary of GlaxoSmithKline Biologicals Current headcount 22 people 4,000 m² of facility of which 400 m² of clean room Collaboration with several partners in the conception and production of vials and lines -IBA: mini e-beam -Technord: automation -Lasea: laser technology -Sirris: material studies -Rexam: vial manufacturing Core technology licensed by Medical Instill Technologies Inc.

14. Copyright © 2008 | Aseptic Technologies | All rights reserved The Crystal ® Closed Vial Technology Has a proven track record of biological drug stability Protects your products from physical and chemical damages Reduces the risk on product loss -Residual volume -Broken vial -Batch rejection Filling suite in our facility to support your compatibility/stability tests in the Crystal ® vials EMEA approved 2 DMF filed at FDA

15. Aseptic Technologies S.A. Rue Camille Hubert, 7-9 B-5032 Gembloux Belgium www.aseptictech.com Copyright © 2008 | Aseptic Technologies | All rights reserved Benoît Verjans Commercial Director Tel: +32 81 409 4direct Fax: +32 81 409 411 Benoit.verjans@aseptictech.com