Therapure Biopharma is a contract development and manufacturing organisation (CDMO) that specialises in the development, scale-up and manufacture of complex biologics.
Therapure operates a modern 130,000ft2 current good manufacturing practice (cGMP) facility in the Greater Toronto Area that is equipped with Class A to C cleanrooms, quality control (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.
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 more than 20 years of experience manufacturing a variety of sources of active pharmaceutical ingredients (API) covering mammalian cell culture, whole blood and plasma, and primary cell culture.
Upstream capabilities include Chinese Hamster Ovary (CHO), HEK-293, hybridoma and stem cell culture, master cell bank creation and media preparation. The company’s downstream expertise includes protein purification, protein modification and large-scale buffer preparation.
Therapure is a recognised global leader in their expertise in the production and purification of whole blood and plasma products.
Therapure is one of the only Canadian companies that offers aseptic fill/finish of glass vials, including Health Canada-licensed aseptic fill/finish suites.
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.
Lyophilisation development and optimisation services are available along with clinical and commercial scale lyophilisation capacity.
Therapure’s diverse group of clients continues to value the quality systems and a 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.