Aseptic Fill/Finish and Lyophilization Therapure BioPharma is a therapeutic protein-specialized Contract Development and Manufacturing Organization (CDMO) that offers a range of biomanufacturing services including technology transfer & process development, analytical development & testing, scale-up & cGMPmanufacturing, aseptic fill/finish, lyophilization and support services. Therapure is the only Canadian company that offers aseptic fill/finish of glass vials, preformed IV infusion bags and prefilled syringes at both clinical and commercial scale. Therapure has significant experience, capabilities and capacity for the fill/finish and lyophilization of therapeutic proteins. Within their 130,000 ft 2 cGMP facility Therapure has Health Canadalicensed aseptic fill/finish suites for glass vials and validated fill/finish suites for IV infusion bags and pre-filled syringes. A Mutual Recognition Agreement (MRA) between Health Canada and the EU allows for selected aseptic fill/finished glass vials produced at Therapure to be sold directly into Europe without receiving county pre-inspections. This shortens time to market and allows for lower inventory requirements for Therapure’s European clients. Therapure offers fill/finish services for their client’s bulk drug substance either produced off-site or as an add-on to Therapure’s own cGMP manufacturing services. Therapure is an ideal partner for biotech companies as they can provide this integrated service from manufacturing to fill/finish to storage and distribution of finished product. Therapure provides lyophilization cycle development and optimization services and in 2010 added commercial lyophilization capacity to its clinical scale lyophilization capabilities allowing production batches in the tens of thousands. Capacities and Volumes :Container Type Vial Filling Preformed IV Bag Filling Prefilled Syringe
Scale Clinical Lyophilization Commercial Lyophilization
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
Chamber Size
# Shelves
1.1 m2 (12 ft 2) 7.5 m2 (81 ft 2)
6 Shelves (114mm) 7 Shelves (100mm)
Temp Batch to Vial Size Range Range -70 to +650C 4,400 Units x 2mL 2,000 Units x 10mL -70 to +800C 32,400units x 2mL 17,100units x 5mL 4,000 units x 50mL
Therapure Biopharma, a proteins development company inspects 100%of the drug product containers prior to final labelling and packaging so as to meet their rigorous quality control standards. Therapure provides warehousing and material handling in their cGMP compliant warehouse for finished goods with next day delivery to clinical and commercial sites throughout North America and Europe. Therapure’s customer focused flexibility, scientific expertise and scalable capacity allows Therapure to adapt to meet the fill/finish and lyophilization needs of its clients at every stage of the development and commercialization process.
By Therapure:- Aseptic Fill/Finish and Lyophilization