Co-leaders: Larry Kwak, M.D., Ph.D. (overall) and David Horne, Ph.D. (small molecule)
 
The primary objective of Core D is to provide process development, regulatory support, and well-documented cGMP-compliant clinical-grade production of characterized CAR T cell products, monoclonal antibodies (mAb), lentivirus vectors, and complex small molecules, including nanomaterials, biopolymers (peptides, siRNA-aptamers, and DNA-peptide hybrids), and complex natural products. We will apply our established project management, product development, regulatory, and manufacturing capability to the benefit of SPORE investigators by providing assistance in pre-clinical development strategy, regulatory affairs, and process devolvement.
 
Quality Assurance, product characterization, and compliance with regulatory requirements for process and product gained from our extensive history of cGMP manufacturing for clinical trials will ensure suitability, control, and scalability of the proposed clinical projects.