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.

Aseptic Fill/Finish & LyophilizationSignificant 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.

Aseptic Fill/Finish & Lyophilization

Aseptic Fill/Finish Services

Lyophilization Services

Container Type Validated Equipment Filling Capacity / Hour Container Volumes (mL)

Vial Filling Bosch TL 3,000 X 2 mL vials 2 - 200

Preformed IV Bag Filling

Plumat Bag Filler 800 bags 50 - 500

Prefilled Syringe Cozzoli 1,200 x 2mL syringes 0.5 - 20

Scale Chamber Size # Shelves Temp Range Batch to Vial Size

Clinical 1.1 m2 6 Shelves 4,400 Units x 2mL (12 ft2) (114mm) -70 to +650°C 2,000 Units x 10mL

7.5 m2 7 Shelves 32,400 units x 2mL Commercial (81 ft2) (100mm) -70 to +800°C 17,100 units x 5mL 4,000 units x 50mL

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.

Therapure Biopharma Inc. 2585 Meadowpine Boulevard, Mississauga, Ontario Canada L5N 8H9

Telephone: +1 905 286 6200 Fax: +1 905 286 6300

www.therapurebio.com

your trusted partner for contract protein development & manufacturing