Workforce Expansion in Biomanufacturing Emerging Technologies

Train-the-trainer programs will be developed at colleges in key biomanufacturing regions in the US. Curriculum, standards and outcomes, SOPs, and batch records will be created and distributed to help hundreds of colleges implement new curriculum.

Industry Need

The size of the pipeline of cell-based and gene-therapy products in the United States forecasts a giant industry with a potential workforce shortage.
Because colleges and universities are not currently prepared to teach the knowledge and skills required to manufacture these products, the industry needs a rapid and robust effort to scale up the preparation of a new workforce to make these new therapies.

Approach

The Workforce Expansion in Biomanufacturing Emerging Technologies (WE-BET) project offers a rapid-response solution that mobilizes, utilizes, and expands on existing decades-long collaborations between colleges across the United States and melds regional efforts into a national effort to train this workforce. This effort will develop and execute train-the-trainer programs at colleges embedded in key biomanufacturing regions in the United States by:

Developing curriculum, standards and outcomes, standard operating procedures, and batch records
Distributing these materials to help hundreds of colleges implement new curriculum to reach thousands of students
Teaching faculty these technologies and the pedagogy required to deliver the core knowledge and the appropriate skills to their students

Since the project uses an existing infrastructure that has operated for decades and leverages the efforts of several existing projects, the effort should be easily sustained after the completion of the one-year project.

Impacts

Development of model curriculum, with skill standards and student learning outcomes, for gene therapy and cell-based therapy and implementation of train-the-trainer sessions to help colleges across the country implement the new curriculum

This project developed a model curriculum, with skill standards and student learning outcomes, for gene therapy and cell-based therapy and implemented train-the-trainer sessions to help colleges across the country implement the new curriculum.

This open-access curriculum is being used by project partners and other colleges to develop courses, training programs, and credentials that will result in highly skilled graduates to help alleviate the workforce shortage the cell and gene therapy sector is currently experiencing.

The creation of novel cell and gene therapy (CGT) curricula and training for biotech education at community colleges and other organizations , leveraging knowledge gained from CGT industry subject matter expert engagement, and the development of new partnerships among institutions that can serve as a bridge to organizations devoted to regenerative medicine like the California Institute for Regenerative Medicine (CIRM) and the World Stem Cell Summit, as well as institutions of higher education in several states.

Value Statement/Outcomes

This project addressed the growing demand for cell and gene therapy technicians by producing key resources, including a labor market analysis, two major reports, and open-access curriculum modules for AAV production, quality control, and regulatory compliance. Disseminated to 199 faculty through train-the-trainer sessions, these outputs enabled new courses, credentials, and graduate placements, creating a scalable model to align education with industry needs and accelerate CGT workforce growth.

Outputs/Deliverables

Comprehensive analysis of CGT workforce demand across six U.S. hubs, highlighting projected growth and skill requirements.

Created lab-based modules for AAV production in HEK293 and Sf9 cells, QC analytics, and immunological assays; integrated into new courses and certificates.

Framework for CGT technician competencies, guiding course design and measurable learning outcomes.

Delivered two virtual train-the-trainer webinars to 199 registrants; disseminated curriculum and SOPs via NBC2 and InnovATEBio platforms.

Presentations

Bryans, M., Cell and Gene Therapy Train-the-Trainer Session 2, Innovatebio Webinar, Virtual, January 24, 2022.

Bryans, M., Cell and Gene Therapy Train-the-Trainer Session I, Innovatebio Webinar, Virtual, December 3, 2021.

Dekloe, J., Cell and Gene Therapy Training, California Biomanufacturing Center Webinar, Virtual, June 11, 2021.

Dekloe, J., Developing the Regenerative Medicine Workforce, Regenerative Medicine, Virtual, November 5, 2021.

Dekloe, J., Toward a Disaster Resilient California: Training the Science Workforce of Tomorrow, California Council on Science and Technology Expert Briefing, Virtual, September 10, 2021.

Workforce Expansion in Biomanufacturing Emerging Technologies (PC2.2-152), NIIMBL Member Forum, Virtual, August 26, 2021.