Cell and biopharmaceutical manufacturing (CBM) is an emerging field and has a wide technical scope. Engineers and managers in CBM must have functional expertise in a wide variety of fields, from cell and biopharmaceutical manufacturing processes and characterization, upstream and downstream processes, and cell and gene therapy, to GMP, quality systems, and regulatory sciences and supply chain management. Students and trainees in CBM have a comparatively short time those in other fields to master new concepts and develop skill sets.
The solution is the creation of courses that challenge students to engage through mental contributions, hands-on activities, and the process of investigation, discovery and interpretation. While listening to lectures or watching videos are generally passive learning on their own, these are methods are enhanced with the thoughtful addition of active learning techniques and activities.
Strategies for incorporating active learning have been developed in the ten course modules. They are embedded into the blended (both on-site and online) courses in various format. These strategies include well-conceived discussion prompts, cooperative group work, adaptive assessments, virtual interactions, synchronous online meetings, developing problem- based learning assignments or activities, and guest lectures by industry partners.
Developed and beta-tested seven industry-informed courses in cell and gene therapy manufacturing, covering GMP, upstream/downstream processing, logistics, Six Sigma, and regulatory/policy issues, addressing critical workforce gaps in biopharmaceutical manufacturing.
Increased accessibility and flexibility by offering courses online and onsite, reducing barriers such as travel and cost, and enabling participation from professionals, educators, and advanced students nationwide.
Equipped trainees with technical skills (e.g., cell processing, viral transduction, GMP compliance) and professional skills (e.g., regulatory filing, IP management, cultural sensitivity), ensuring a well-rounded workforce prepared for emerging biomanufacturing challenges.
Benefits NIIMBL members and educators by creating shared instructional resources and fostering collaboration between academia and industry, strengthening the U.S. biomanufacturing talent pipeline.
This project delivered a comprehensive suite of seven biopharmaceutical manufacturing courses, designed collaboratively by academic and industry partners, and made accessible through NIIMBL’s Education & Training portal. These courses provide measurable outcomes such as improved technical and regulatory competencies, enhanced accessibility for diverse learners, and the potential foundation for future certificate and professional degree programs. By addressing critical workforce gaps, the project ensures sustainable talent development for the biopharmaceutical industry.
Seven courses developed and beta-tested, including topics on GMP, Six Sigma, logistics, upstream/downstream processing, and cell manufacturing ethics and policy.
Participation metrics: 41 individuals engaged during beta testing (20 higher-ed students, 7 educators, 14 professionals), validating course relevance and usability. Over 1,800 individuals have taken these courses to date
Courses integrated into NIIMBL’s Education & Training portal and academic platforms (Georgia Tech Professional Education and UGA CTL), ensuring long-term accessibility and scalability.
Inclusion of innovative learning tools, such as a Virtual Reality component for upstream processing, enhancing engagement and comprehension of complex biomanufacturing processes.
Levine, A., FDA Oversight of Cell Therapies & The Challenge of Unproven Cell Therapies, Virtual, October 2, 2020.
The Excellence in Biopharmaceutical Manufacturing Education and Training (EBMET) (PC1.0-026), NIIMBL Member Forum, Virtual, November 19, 2020.
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Georgia Tech Research Corporation
Akron Biotechnology, LLC
Cogent Biosciences
Merck Sharp & Dohme LLC
RoosterBio Inc
University of Georgia Research Foundation
