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 & cGMP
manufacturing, 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
pre-filled 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 ft2 cGMP facility Therapure
has Health Canada- licensed 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 Filling Capacity / Container Volumes (mL)

Hour
Vial Filling 3,000 X 2 mL vials 2 - 200
Preformed IV Bag Filling 800 bags 50 – 500
Prefilled Syringe 1,200 x 2mL syringes 0.5 - 20

Scale Chamber Size # Shelves Temp Batch to Vial Size

Range Range
Clinical Lyophilization 1.1 m2 6 Shelves -70 to +650C 4,400 Units x 2mL
(12 ft2) (114mm) 2,000 Units x 10mL
Commercial 7.5 m2 7 Shelves -70 to +800C 32,400 units x 2mL
Lyophilization (81 ft2) (100mm) 17,100 units 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