Uw Program For Advanced Cell Therapy

Our mission is to enable UW researchers and clinicians as well as external partners to develop advanced cell & gene therapies through FDA CBER IND-enabling and Phase I/II clinical studies. We provide place-of-care vein-to-vein (POCV2V) cell therapy manufacture, regulatory and capitalizing our UW Health clinical center of excellence for clinical deployment capabilities. Our vision is to enable BLA line of sight development and deployment of POCV2V cell technologies. We assist in the development of Standard Operating Procedures and Batch Production Records in support of new FDA CBER INDs. Our team optimizes the manufacturing processes, including FDA-compliant production of variety of cell types, advanced cell manufacturing and cell enrichment. We offer services to assist researchers and clinicians in various aspects of IND filing including writing/reviewing of CMC and supporting reports. We are engaged in several Phase I clinical trials and are open to multi center trials for academic and clinical-stage companies in cell technology space. We partner with biotechnology and medical device companies to integrate their semi-automated and fully automated devices to improve GMP workflow. We welcome academic and industry partners to work with us to design new technologies/devices or improve existing technologies/devices that can be used in the GMP cell manufacturing laboratories.