Therapure's Biotech manufacturing targets Clients' Scale Up & cGMP Manufacturing needs Therapure Biopharma is a Contract Development and Manufacturing Organization (CDMO) that specializes in the development, scale up and manufacture of protein therapeutics and protein purification. Therapure operates a modern 130,000 ft2 cGMP facility 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. This facility coupled with the skilled staff provides clients with a complete range of integrated biomanufacturing services.
Technology Transfer & Process Development : The technology transfer program combines Therapure’s significant experience developing proteinbased products with clients’ product specific knowledge to create a costeffective and efficient development program. Therapure’s process development services include: vector design and construction, host cell line optimization, cell banking, upstream & downstream processing and buffer formulation development. Analytical Development & Testing : Therapure can support client needs with robust and reliable analytical methods that are used to support inprocess analysis, bulk and drug product release testing and stability monitoring programs. Therapure has expertise in developing product specific assays and in the development, qualification and validation of cGMP compliant analytical methods including complex biological activity assays.
Scale Up & cGMP Manufacturing : With 28,000 ft2 of cGMP manufacturing space including pilot, clinical and commercial scale production capacity Therapure is able to meet their client’s scale up needs. Therapure has >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, HEK293, 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 : 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 Health Canada licensed aseptic fill/finish suites for glass vials and validated fill/finish suites for IV infusion bags and prefilled 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 preinspections. Lyophilization development and optimization services are available along with clinical and commercial scale lyophilization capacity.
Support Services :
Therapure’s support services were designed to provide a complete biomanufacturing service offering, thereby minimizing logistics and providing one point of contact. Warehousing and material handling are provided with 24/7 access control and monitoring in a range of environments including freezers, walkin cold rooms, incubators and explosion rated rooms. Therapure’s validated shipping protocols allow them to provide next day delivery in North America and Europe. Therapure also offers validation support and stability testing compliant with ICH guidelines. Therapure’s diverse group of clients continues to value the quality systems and broad range of biomanufacturing services that Therapure provides. The integrated service offering allows clients to remain with Therapure throughout the development and commercialization stages of production. By : Therapure Biopharma Inc