A critical step for TFBS Bioscience to enable the manufacturing of clinical-grade lentiviral vectors in its Taipei facility and ready to supply viral vectors for the global needs of cell and gene therapies
PELL BIO-MED TECHNOLOGY announced entering the phase 1/2 clinical trial of refractory B-cell lymphoma with its first CAR-T cell product. The patients will receive CAR-T cell therapy by using clinical-grade lentiviral vector supplied by TFBS Bioscience. Since the announcement of the strategic partnership between PELL BIO-MED TECHNOLOGY and TFBS Bioscience in 2021, the entire manufacturing process and regulatory submission was completed in less than one year, from technology transfer and process development to manufacturing of clinical material. The successful regulatory review and approval of PELL’s CAR-T product has demonstrated the capability of TFBS Bioscience in viral vector manufacturing. PELL BIO-MED TECHNOLOGY is developing the CAR-T products with its proprietary cell engineering and processing technology. The collaboration with TFBS Bioscience in GMP viral vector production is necessary for PELL to build a strong and reliable supply chain in Taiwan.
TFBS Bioscience is able to provide a wide spectrum of services, from plasmid generation, process development, GMP manufacturing, and analytical method development. TFBS can offer flexible and customized manufacturing package of various viral vectors, including lentivirus and adeno-associated virus (AAV). The goal of project management is to create values for our customer in a goal-oriented and time-saving manner. TFBS Bioscience will continue to prove its manufacturing capability and capacity in the late-stage production of viral vectors with its phase 3/commercial facility to be commissioned in 2024.
ABOUT PELL BIO-MED TECHNOLOGY
PELL BIO-MED TECHNOLOGY CO., LTD. was established in March, 2017, becoming the first biomedical company in Taiwan to specialize in the development of cell culture technologies and techniques for therapeutic applications. The founder, Prof. Chen-Lung Lin is currently Chair Professor at Imperial College in London, an honorary professor of the Departments of Surgery and of Pathology at the University of Hong Kong. With a strong commitment to his profession, he has also been recognized as a fellow for the Royal College of Surgeons of England as well as the British Society for Immunology in the UK.
ABOUT TFBS BIOSCIENCE
TFBS Bioscience Inc. was founded in 2016 as the first Contract Research Organization (CRO) providing biological testing in Taiwan. Our technical team's roots run deeper, going back to the virus research laboratory founded in 2009 at the Development Center of Biotechnology (DCB), a government-sponsored research institute in Taiwan. TFBS has established good reputation and track records in several regulatory submissions, winning trust from the international regulatory agencies and biopharmaceutical industry. TFBS has launched the first viral vectors Contract Development and Manufacturing Organization (CDMO) facility in Taiwan, providing fully integrated end-to-end contract development and manufacturing services for the needs of clinical trials. Nowadays, with our manufacturing expertise and state-of-the-art facility, we are determined to be the best partner offering clients a one-stop-shop solution for gene and cell therapy. For more information, please visit www.tfbsbio.com/.