4324 Phase 1 Sterile Product Formulation and Manufacturing at Academic Medical Centers: An Introduction for Translational Researchers

Choosing AMC resources vs outside consultants and vendors, leveraging local resources where possible. Qualifying and monitoring suppliers, testing laboratories, in-house departments, and Contract Drug Manufacturing Organizations (CDMO). Bringing together the deliverables for the IND CMC section. Where and how to leverage available products and science to simplify safe and reliable production. DISCUSSION/SIGNIFICANCE OF IMPACT: Use and utility of injectable drug products, both small molecule and biologics, is growing rapidly, and is projected to continue to escalate well into the next decade. This is due not only to advances in medicine, but also to improvements in AMC-based sterile product production, and a better understanding of small batch manufacturing methods. All three trends align in academic medical centers (AMC) and can be utilized by translational researchers, if they can understand the potential and regulatory requirements.