Hands-on cGMP Biomanufacturing of Vectors for Gene Therapy

Receive hands-on training in the production of vectors for gene therapy products using an AAV2-GFP model system in a Sf9/Baculovirus system. Engage in upstream operations (suspension cell culture, vector production scale-up in 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.  Attend and you will be able to:

• 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
• Harvest vectors using scalable operations and describe options for harvest process design
• Purify vectors 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

Fees of $3,600 include:

• 30 hours of instruction (3.0 CEUs)
• Notebook containing all course lecture and lab materials
• Morning coffee and lunch
• Certificate of attendance/completion