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.

1. 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
& 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.
Aseptic Fill/Finish & Lyophilization

2. 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