cGMP ASEPTIC FILL / FINISH
Passion for your process, product and patients
Therapure Biomanufacturing is a contract development and manufacturing organization (CDMO) that places product quality and patient safety at the forefront.
A key aspect related to product quality, and one of the final steps in the manufacturing process, is aseptic fill/finish. Therapure’s state-of-the-art cGMP facility supports aseptic fill/finish of your biologic and small molecule products from clinical trial material through to commercial manufacturing.
We provide the following services for aseptic fill/finish of your high-value drug product:
- Peristaltic pump–based systems, which use a disposable fill configuration with minimal line loss
- High degree of accuracy and ability to fill small volumes
- Wide range of batch and vial sizes
Integrated lyophilization capabilities for clinical and commercial products
- 81 ft2 (7.5 m2)
- 7 shelves
- Temperature range -70°C to +80°C
- 43 ft2 (4.0 m2)
- 5 shelves
- Temperature range -70°C to +80°C”
- Cozzoli® nested-tub syringe filler with syringe sizes from 0.5–30 mL and fill speeds up to 1,200 syringes per hour
As part of our integrated quality systems, our team performs 100% visual inspection of the drug product containers prior to labeling, which is followed by packaging and cartoning. As well, we have the ability to develop and execute ICH-compliant stability protocols.
Your high-value finished product is stored in our cGMP warehouse and shipped using validated shipping protocols for next-day North American delivery to your clinical or commercial sites.