Hands-on Training for GMP Manufacturing: Best Practices, Partnerships, and Pitfalls

B.A. Reeves
National Center for Therapeutics Manufacturing, Texas A&M University,
United States

Keywords: Biomanufacturing, Hands-on, apprenticeship, mRNA, recombinant proteins, viral vectors

Summary:

The National Center for Therapeutics Manufacturing (NCTM) is a simulated GMP facility, established with seed funding from the Biomedical Advanced Research and Development Authority (BARDA), built to support hands-on training for the biomanufacturing industry. Over the past 15 years, NCTM has developed and launched a large portfolio of training courses in multiple delivery formats, but NCTM’s specialty remains hands-on training, conducted using actual process streams. Currently, NCTM runs training courses for recombinant proteins, vaccines, viral vectors, and mRNA platforms, ranging from entry level technician training to continued education for seasoned industry professionals on advanced topics. This presentation will discuss NCTM’s course development methodology, leveraging partnerships with industry, and common pitfalls for workforce training organizations and how to navigate them. In addition, it will cover the development and launch of NCTM’s Hands-on Manufacturing of mRNA Vaccines and Therapeutics course as a case study. This course, developed in collaboration with Pfizer and several other industry partners, was the world’s first manufacturing-scale, hands-on training program for mRNA products.