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.
Aseptic Fill/Finish Services Container Type
Validated Equipment
Filling Capacity / Hour
Container Volumes (mL)
Bosch TL
3,000 X 2 mL vials
2 - 200
Plumat Bag Filler
800 bags
50 - 500
Cozzoli
1,200 x 2mL syringes
0.5 - 20
Vial Filling Preformed IV Bag Filling Prefilled Syringe
Lyophilization Services Scale
Temp Range
Batch to Vial Size
1.1 m 2 6 Shelves -70 to +650째C (12 ft 2) (114mm)
4,400 Units x 2mL 2,000 Units x 10mL
7.5 m 2 7 Shelves Commercial -70 to +800째C (81 ft 2) (100mm)
32,400 units x 2mL 17,100 units x 5mL 4,000 units x 50mL
Clinical
Chamber Size
# Shelves
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: +1 905 286 6200 Fax: +1 905 286 6300
www.therapurebio.com