Qyntessa’s flexible, multi-product manufacturing facility is designed to produce a variety of biological products for Phase I and Phase II clinical trials. Our facility design uses uni-directional people and material flows, strictly controlled air pressure differentials, and strategically placed anterooms to protect products from contamination while safely containing biosafety level BL1 and BL2 materials.
Product change-over procedures for all production spaces include vaporous hydrogen peroxide treatment and validated cleaning procedures. CGMP compliance is ensured by Quality Assurance oversight of the entire process from receipt of cell and viral seed stocks, through equipment and systems validation, through drafting and approval of batch records and other required documents, to the release of the product to the client and ongoing stability testing.
Qyntessa’s compliance program utilizes a systems approach, selected and approved vendors, documentation and change control, and a rigid approval system for all manufacturing and testing procedures.