Therapure Biopharma is a Contract Development and Manufacturing Organization (CDMO) that specializes in the development, scale up and manufacture of complex biologics.
Therapure operates a modern 130,000 ft2 cGMP facility in the Greater Toronto Area that is equipped with Class A to C clean rooms, QC and analytical labs, clinical and commercial scale manufacturing suites, mammalian cell culture production capability with upstream and downstream processing and aseptic fill/finish capacity.
cGMP biologic manufacturing
With 28,000 ft2 of cGMP biomanufacturing space including pilot, clinical and commercial scale production capacity Therapure is able to meet client's scale-up needs. Therapure has over 20 years of experience manufacturing a variety of sources of API covering mammalian cell culture, whole blood and plasma and primary cell culture.
Upstream capabilities include: CHO, HEK-293, hybridoma and stem cell culture, master cell bank creation and media preparation. Downstream expertise includes: protein purification, protein modification and large scale buffer preparation. Therapure is a recognized global leader in their expertise in the production and purification of whole blood and plasma products.
Aseptic fill / finish & lyophilization of complex proteins
Therapure is the only Canadian company that offers all of the following services: aseptic fill/finish of glass vials, preformed IV infusion bags and pre-filled syringes at both clinical and commercial scale. 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 Canada and the EU allows for selected aseptic fill/finished glass vials produced at Therapure to be sold directly into Europe without receiving country pre-inspections. Lyophilization development and optimization services are available along with clinical and commercial scale lyophilization capacity.
Scale up and cGMP manufacturing
Therapure's diverse group of clients continues to value the quality systems and broad range of biomanufacturing and fill/finish services that Therapure provides. The integrated service offering allows clients to remain with Therapure throughout the development and commercialization stages of production.