Hands-On Biomanufacturing of Vectors for Gene Therapy
Obtain hands-on training in the production of vectors for gene therapy products using an AAV2-GFP model system in both HEK293 cells and Sf9/Baculovirus systems. Engage in pilot/manufacturing-scale upstream operations (adherent and suspension cell culture, vector production scale-up in cell stacks and single-use bioreactors); downstream operations (cell lysis, product recovery via depth filtration, purification using chromatography, and ultrafiltration for concentration and buffer exchange); and analytical technologies, as well as discuss strategies and issues around scale-up, tech transfer, and adherent vs. suspension cultures.
| Dates | Course | Cost | Registration |
|---|---|---|---|
| May 12-13, 2026 | Artificial Intelligence in FDA-Regulated Manufacturing: From Foundations to Implementation | $1,500 | Register |
| May 20–21, 2026 | Hands-On Essentials of Automation for Biomanufacturing | $2,050 | Register |
| May 27–29, 2026 | Preparative Chromatography Column Packing: Lab to Process Scale | $2,500 | Register |
| June 3–4, 2026 | Applied Cleaning Validation Practices: A STERIS Master Class | $2,000 | Register |
| June 9–10, 2026 | Introduction to Biopharmaceutical Lyophilization | $1,975 | Register |
| June 11, 2026 | Essentials of Spray Drying and Powder Analysis | $995 | Register |
| June 16–18, 2026 | Fundamentals of Mammalian Cell Line Development | $3,100 | Register |
| June 23–25, 2026 | Biopharmaceutical Assay Essentials | $3,100 | Register |
| June 23–25, 2026 | Fermentation Engineering | $3,100 | Register |
| June 30–July 2, 2026 | Hands-On Principles of mRNA Technology | $2,500 | Register |
| July 8–10, 2026 | Downstream Biopharmaceutical Processes: Fundamentals and Design | $3,100 | Register |
| July 14–16, 2026 | AAV Quality Attributes: Theory and Practice | $2,975 | Register |
| July 14–17, 2026 | Hands-On cGMP Biomanufacturing Operations | $4,200 | Register |
| July 28–31, 2026 | Hands-On Biomanufacturing of Vectors for Gene Therapy | $4,500 | Register |
| Aug 6, 2026 | Design of Experiments for Biomanufacturing | $500* | Register |
| Sept 29–Oct 1, 2026 | Cell Culture Engineering | $4,200 | Register |
| Oct 13–16, 2026 | Applied Principles and Techniques of Depth Flow Filtration (DFF) and Tangential Flow Filtration (TFF) for BioPharm Purification | $3,995 | Register |
| Nov 10–12, 2026 | PAT for Real-time Culture Monitoring and Closed-Loop Process Control | $2,975 | Register |
| TBD | Microbial Contamination Control in Bioprocessing Operations | $2,975 |
Attend and you will learn
- List key CGMP (current Good Manufacturing Practice) requirements/expectations
- Describe the unit operations commonly used for production of gene therapy vectors, including their purpose, underlying principles, and operation
- Culture adherent and suspension cell lines
- Optimize transient transfection conditions
- Harvest vector using scalable operations and describe options for harvest process design
- Purify vector using appropriate resins and AKTA chromatography systems
- Formulate drug substance by ultrafiltration
- Perform basic scale-up calculations for operations involved
- List parameters that are monitored and/or controlled to ensure acceptable process performance
- Calculate step yields for downstream operations
- Describe analytical tools used in assessing and characterizing gene therapy products and processes
Delivery methods
35% Lecture
10% Discussion/group activity
55% Hands-on lab experience
Course content
20% Fundamentals and concepts
70% Industry applications
10% Emerging technologies
30 hours of instruction
Who should attend
Anyone interested in obtaining basic knowledge and hands-on exposure to production-scale biomanufacturing operations used in the manufacturing of vectors for gene therapy products, such as the following:
- New or existing biomanufacturing employees taking on a new assignment focused on gene therapy
- Research scientists from academia or industry interested in gaining knowledge of CGMP manufacturing of AAV vectors
- Biomanufacturing personnel who may not be directly involved with the process they support, including Validation, QA, or QC staff
- Suppliers of components and contractors providing services to companies manufacturing viral vectors
This course was developed with a project award from the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and financial assistance from the U.S. Department of Commerce, National Institute of Standards and Technology (70NANB17H002).
Additional support has been provided by the North Carolina Biotechnology Center.