Gene therapy is a rapidly developing treatment option. Despite this growth, there are limited opportunities for training in the area of gene therapy vector manufacturing.
The solution is the Gene Therapy Training Network (GTTN). The network will enable development of courses related to gene therapy, transfer of these courses to other institutions within the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), and standardization of course content and curriculum for professionals.
Comprehensive guide detailing course objectives, lab protocols, assessment methods, and preparation steps for gene therapy training.
Documented process for transferring technical, lab-intensive courses between institutions, applicable to other biopharma disciplines.
Offered a 4-day “Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy” course at NCTM with full enrollment.
Improved AAV production protocols, developed chromatography steps for capsid separation, and created an HPLC method for quantifying full and empty capsids for instructional use.
This project advanced gene therapy workforce development by transferring a complex, lab-intensive short course from NC State’s BTEC to Texas A&M’s NCTM, culminating in a pilot that trained 13 professionals and educators. Deliverables included an instructor’s manual, a standardized SOP for course transfer, and improvements to AAV production processes—boosting titers, adding new serotypes, and developing an HPLC method for capsid analysis. These outputs create a scalable training model, expand access to specialized skills, and ensure industry-relevant content for the rapidly growing gene therapy sector.
Comprehensive guides for course delivery and transfer, applicable to other lab-intensive biopharma training programs.
Conducted a 4-day hands-on gene therapy course at NCTM with 13 professional participants and trained nine educators.
Scheduled three additional course offerings at NCTM and ongoing delivery at BTEC, ensuring sustainability and scalability.
Increased AAV titers using improved cell systems, developed chromatography steps for capsid separation, and optimized an HPLC method for full/empty capsid quantification.
Overton, L., Boi, C., Shastry, S., Smith-Moore, C., Balchunas, J., Sambandan, D., & Gilleskie, G. (2023). Development and Delivery of a Hands-On Short Course in Adeno-Associated Virus Manufacturing to Support Growing Workforce Needs in Gene Therapy. Human Gene Therapy, 34(7-8), 259-272. https://doi.org/10.1089/hum.2022.235
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North Carolina State University
Texas A&M University System
