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Slide 1: Aseptic Fill/Finish & Lyophilization Aseptic Fill/Finish & Lyophilization Significant time and cost have been incurred to produce the bulk drug substance for your program. You are now searching for a partner you can trust to formulate, fill and finish into your desired final product container. Who can you trust with your valuable bulk material? Therapure is your trusted partner for cost-effective clinical and commercial scale fill/finish services. Therapure has validated aseptic fill/finish suites for cost effective formulation, filling and finishing of clinical and commercial scale products. Therapure has experience filling and finishing both therapeutic proteins and small molecules into vials, preformed IV bags and prefilled syringes. Therapure also offers integrated lyophilization capabilities at both the clinical and commercial scale. Our fill/finish suites and support systems were inspected and licensed by Health Canada in 2009. The fill/finish suites are scheduled to undergo multiple FDA pre-approval inspections in 2011.
Slide 2: Aseptic Fill/Finish Services Container Type Vial Filling Preformed IV Bag Filling Prefilled Syringe Validated Equipment Bosch TL Plumat Bag Filler Cozzoli Filling Capacity / Hour 3,000 X 2 mL vials 800 bags 1,200 x 2mL syringes Container Volumes (mL) 2 - 200 50 - 500 0.5 - 20 Lyophilization Services Scale Clinical Chamber Size 1.1 m 2 (12 ft 2) 7.5 m 2 (81 ft 2) # Shelves 6 Shelves (114mm) 7 Shelves (100mm) Temp Range -70 to +650°C Batch to Vial Size 4,400 Units x 2mL 2,000 Units x 10mL 32,400 units x 2mL 17,100 units x 5mL 4,000 units x 50mL Commercial -70 to +800°C Therapure will actively involve you in the implementation of your fill/finish project. Once the product is filled and finished, we perform 100% inspection of the drug product containers prior to labelling, and then finish with packaging and cartoning. We also offer storage and distribution services to your clinical or commercial sites. These services are designed for one goal; to be your one-stop for everything related to aseptic fill/finish & lyophilization. your trusted partner for contract protein development & manufacturing Therapure Biopharma Inc. 2585 Meadowpine Boulevard, Mississauga, Ontario Canada L5N 8H9 Telephone: Fax: +1 905 286 6200 +1 905 286 6300 www.therapurebio.com