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BTEC Offers Hands-On cGMP Biomanufacturing of Vectors for Gene Therapy Course

The Biomanufacturing Training and Education Center (BTEC) at North Carolina State University will offer a four-day course focused on the production of gene therapy vectors. The course will take place May 13-16, 2019.


This course was developed as part of a NIIMBL-funded project, Preparing for the Future: A Gene Therapy Vector Production Platform. The project aims to develop a platform process for the production, purification, and analysis of adeno-associated virus (AAV) vectors used for gene therapy. In addition to developing a platform process, the project also provides hands-on training on gene therapy vector production.  


This hands-on training will provide students with an overview of pilot/manufacturing-scale upstream and downstream biomanufacturing operations for the production AAV vectors used in gene therapy. Topics include:


  • Introduction to gene therapy products
  • Overview of cGMP as it relates to 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


Registration is open to NIIMBL members through January 31, 2019. After January 31, 2019 registration will open to the general public, including NIIMBL members, based on availability. NIIMBL members received a 40% discount on the course fee. Please select NIIMBL Members in the price drop-down during registration.


Additional Information


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Registration Link (currently open to NIIMBL members only):


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