Shanghai Sinobioway Sunterra Biotechnology (SSSB) and F1 oncology initiate new development, manufacturing, and supply to finish a new cGMP manufacturing facility in Shenzhen with the aid of lentivirus contract manufacturing. Shenzhen Biowit is slated for completion in 2018 entailing F1 Oncology’s chemically defined suspension-based lentivirus manufacturing technology and processes. The collaboration eyes facilitation of future China gene therapy markets possessing clinical and commercial cGMP lentivirus for gene therapies. It will also enable facilitation of clinical development and commercialization of CCT3- based conditionally active biologic chimeric antigen receptor T cell (CAB-CAR-T) products in China, Hong Kong, Macau, and Taiwan as F1 Oncology retrieves and authorizes to manufacture and supply exclusive product classes. As part of the collaboration, F1 Oncology is held accountable for generating leads, assessing preclinical safety and clinical virus manufacturing costs whereas Sinobioway Sunterra Biotechnology will be responsible for cGMP cell processing, clinical development, regulatory approval, and commercialization accounting for F1 Oncology’s processing of raw materials in order to supply commercial products to the China markets.
Mr. Wu Zili, Board Director and founder of SSSB conveyed confidence by asserting “Biowit, a subsidiary of SSSB, has been providing the majority of cell therapy research institutions in China with virus products service over the past 7 years. Today, the introduction of F1 Oncology’s chemically defined suspension-based lentivirus manufacturing technology marks a new stage of China clinical virus manufacturing. Through our one-year-old collaboration, Sunterra is leveraging the value of F1 Oncology’s CAB-CAR-T technology and proprietary industrial manufacturing processes to begin novel CAR-T clinical trials in China. We are confident that F1 Oncology’s differentiating technologies will allow us to stand out from other players in the CAR-T solid tumor space.”