Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy Course

In this brand new four-day course, you will obtain hands-on training in the production
of vectors for gene therapy products using an AAV2 model in both HEK293
and Sf9/Baculovirus systems. The course will provide an overview of pilot/
manufacturing-scale upstream and downstream biomanufacturing operations.

Major topics include:

• Introduction to gene therapy products, including the principles and challenges
• underlying gene therapy treatment.
• Overview of cGMP as it relates to production of gene therapy vectors.
• Upstream processing: adherent vs suspension cell culture, baculovirus generation,
• optimization of transient transfection conditions, vector production, scale-up in
• cell stacks and single-use bioreactors.
• Downstream processing: cell lysis techniques, recovery via filtration and centrifugation, purification using chromatography, and ultrafiltration for product formulation and bulk filling.
• Characterization and analysis of gene therapy processes and products.