Beginnings: Diversifying Talent in Advanced Biologics Manufacturing

Texas A&M Engineering Experiment Station, College Station TX

Investigators

Abstract

The National Center for Therapeutics Manufacturing (NCTM), a center within the Texas A&M Engineering Experiment Station (TEES)’s ExLENT project “Beginnings: Diversifying Talent in Advanced Biologics Manufacturing – mRNA Vaccines and Gene Therapies (DTABM)” will address the national skills gap in advanced biologics manufacturing. This project will deliver hands-on training in a simulated cGMP, pilot-scale facility, to build a highly skilled, technical workforce for future jobs in biomanufacturing. NCTM’s training programs are thoroughly vetted by biologics manufacturing companies and has enabled graduates to obtain jobs with companies in the biopharmaceutical industry. At the end of the 3-year performance period of the DTABM initiative, 90 skilled trainees will be ready for employment in the emerging biomanufacturing industry, specifically skilled in manufacturing processes for the production of recombinant proteins, viral vectors for gene therapy, and mRNA-based vaccines and therapeutics. Preparing trained operators and technicians to meet workforce needs for biopharmaceutical manufacturing aligns with the goals of the Manufacturing USA Institutes, specifically the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and the Advanced Regenerative Manufacturing Institute (ARMI). Finally, the DTABM initiative is committed to promoting diversity, equity, inclusion, and accessibility within the advanced biomanufacturing industry. NCTM will partner with MSI colleges and universities to increase accessibility to underserved populations and boost the employability of these students, thereby contributing to a more diverse workforce. NCTM offers a customizable, online, hands-on, and instructor-led training covering all aspects of biomanufacturing, including upstream and downstream processing for biologics production, analytics, Current Good Manufacturing Practices (cGMP), quality systems, and regulatory compliance. All training is designed, developed, and delivered by industry professionals and academic subject matter experts and is unique in the following ways. First, all training courses are delivered in a small cohort model, where class size is capped at 10-12 participants to ensure each trainee has extensive hands-on time with each piece of equipment. Second, NCTM performs training in a simulated cGMP facility, allowing for a comprehensive training regime that includes important aspects of manufacturing, including gowning, personnel and material flow through controlled airlocks, functional adjacencies, and other concepts that are typically overlooked in many training courses. Third, the equipment utilized during NCTM training is industry-standard, pilot- or manufacturing-scale equipment, which gives participants a unique opportunity to train on skids relevant to their current or future careers in biomanufacturing. This project will provide pre-hire industrial training to students who will fill the workforce pipeline in Texas, Louisiana, North Carolina, and Maryland, as NCTM has long-standing partnerships with the MSIs in each of these states. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.