BriaCell sources raw materials, active pharmaceutical ingredients, and finished product candidates for clinical trials through internal resources and third-party consultants managing manufacturing contractors. Bria-IMT™ is manufactured under current Good Manufacturing Practices (cGMP) through agreements with UC Davis and FujiFilm Diosynth Biotechnology ("Fuji") in Thousand Oaks, California. UC Davis produces Bria-IMT™ at its GMP facility under an agreement dated June 11, 2015. On July 5, 2022, BriaCell entered a manufacturing service agreement with Waisman Biomanufacturing at the University of Wisconsin-Madison to manufacture Bria-Pros™ for clinical studies. Fuji manufactures Bria-IMT™ for clinical studies, including Phase 3, under a master services agreement dated May 29, 2023. Both Waisman and Fuji are contract manufacturing organizations specializing in cellular therapies for clinical trials. Bria-IMT™ cells are grown, harvested, irradiated, cryopreserved, and stockpiled by Fuji and UC Davis, with each lot tested for potency, identity, and contamination. Additional manufacturing facilities may be engaged as demand increases.
Briacell Therapeutics's Comment on Supply Chain
BriaCell sources raw materials, active pharmaceutical ingredients, and finished product candidates for clinical trials through internal resources and third-party consultants managing manufacturing contractors. Bria-IMT™ is manufactured under current Good Manufacturing Practices (cGMP) through agreements with UC Davis and FujiFilm Diosynth Biotechnology ("Fuji") in Thousand Oaks, California. UC Davis produces Bria-IMT™ at its GMP facility under an agreement dated June 11, 2015. On July 5, 2022, BriaCell entered a manufacturing service agreement with Waisman Biomanufacturing at the University of Wisconsin-Madison to manufacture Bria-Pros™ for clinical studies. Fuji manufactures Bria-IMT™ for clinical studies, including Phase 3, under a master services agreement dated May 29, 2023. Both Waisman and Fuji are contract manufacturing organizations specializing in cellular therapies for clinical trials. Bria-IMT™ cells are grown, harvested, irradiated, cryopreserved, and stockpiled by Fuji and UC Davis, with each lot tested for potency, identity, and contamination. Additional manufacturing facilities may be engaged as demand increases.
Sources:
Briacell Therapeutics Corp 's official press releases and regulatory filings; CSIMarket.com's supply-chain research; and the financial filings and press releases of other companies cited in this report.
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