BioFactura's CDMO Evolution: Jeffrey Hausfeld and Darryl Sampey on Capitol Biologics

In this episode of BioTalk with Rich Bendis, Jeffrey N. Hausfeld, M.D., Chairman of the Board and Chief Medical Officer of BioFactura Inc., and Darryl Sampey, Ph.D., President and Chief Executive Officer of Capitol Biologics, join the conversation to discuss the launch of Capitol Biologics as BioFactura's CDMO division. Jeff and Darryl explain how BioFactura's experience building biologics development and clinical manufacturing capabilities created the foundation for a more personalized CDMO model. The discussion explores the gap Capitol Biologics is designed to fill for emerging biotech companies that need integrated development support, scientific depth, analytical expertise, phase-appropriate quality, and early GMP manufacturing without being pushed into a large commercial-scale CDMO model too soon. The conversation also highlights what biotech CEOs and CMC leaders should consider before choosing a CDMO partner, including developability assessment, cell line and process development, analytical characterization, quality systems, cost of goods, regulatory readiness, and timing. Jeff and Darryl also discuss the growing importance of U.S.-based biologics development and manufacturing capacity, especially for emerging biotech and government-aligned programs. Editing and post-production work for this episode was provided by The Podcast Consultant. Jeffrey N. Hausfeld, M.D., M.B.A., F.A.C.S., is a physician entrepreneur, biotechnology executive, investor, and healthcare innovator whose career spans clinical medicine, life sciences, healthcare real estate development, and entrepreneurial leadership. A graduate of Yale University School of Medicine and recipient of an M.B.A. from Johns Hopkins University, Dr. Hausfeld is an Associate Clinical Professor of Surgery at George Washington University and has been actively involved in national medical societies and healthcare leadership organizations for more than four decades. He currently serves as Chairman of the Board and Chief Medical Officer of BioFactura Inc., Chairman of Capitol Biologics, and Chairman and Co-Founder of the Society of Physician Entrepreneurs. His work focuses on advancing healthcare innovation, biotechnology commercialization, physician entrepreneurship, and the responsible adoption of emerging technologies that improve patient care. Darryl Sampey, Ph.D., is a biopharmaceutical executive and company builder with more than 30 years of experience advancing biologics from discovery through clinical development and commercial manufacturing. He co-founded BioFactura in 2004 and has guided the company from start-up through incubator stages into a fully integrated biopharmaceutical product development and clinical manufacturing company. At BioFactura, he has raised more than $90 million in non-dilutive and strategic funding, built cGMP manufacturing capabilities, and led development of novel therapeutics, biodefense medical countermeasures, biosimilars, and cell therapies. Dr. Sampey is an inventor of the VeriCyte™ Discovery and StableFast™ Biomanufacturing Platforms and previously held process development and manufacturing leadership roles at Human Genome Sciences and North American Vaccine.