Project A-Cell
Jim Beltzer, Ph.D., Principal Consultant, Cell and Gene Therapy, contributed to Project A-Cell, recently released by the Alliance for Regenerative Medicine (ARM) and the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL).
According to a press release issued by ARM, the multistakeholder collaboration, which incorporates Quality by Design (QbD) principles into a manufacturing case study of a Chimeric Antigen Receptor T-cell (CAR-T) therapy, brings best practices and a standard methodology for Chemistry, Manufacturing and Controls (CMC) to the cell-based therapy field.
“I became involved with Project A-Cell while working at a major life sciences tool provider company that specializes in cell therapy manufacturing and blood banking,” says Dr. Beltzer. “As a subject matter expert in stem cell biology with experience in automated cell culture using bioreactors and, specifically, hollow fiber bioreactors, I was offered the opportunity to contribute to Chapter 8 of Project A-Cell, ‘Manufacturing of Cell-Based Therapies.’”
Dr. Beltzer is a biochemist and cell biologist with more than 25 years of industry experience in research and development and more than 15 years of experience in regenerative medicine. He worked at several start-up biotechnology companies in the Boston area, specializing in drug discovery, phage display technologies, and high-throughput process development for biomanufacturing.
According to ARM, more than 50 industry experts from more than 30 leading therapeutic developers, as well as regulatory experts and the Standards Coordinating Body, contributed to Project A-Cell.
To learn more, visit alliancerm.org.
