Current production methods for viral vectors tend to use adherently growing cells and transient transfection, a manual process which allows only for scale-out and not for scale-up. Upscaling GMP production of viral vectors is currently one of the big technical challenges in gene therapy manufacture. CEVEC has developed the fully scalable CAP-GT platform, based on serum-free suspension cells which can efficiently produce lentivirus (LV), adenovirus (AV) and adeno-associated virus (AAV) vectors at industrial scale.
Watch this On Demand webinar with Dr Nicole Faust, CEO & CSO of CEVEC Pharmaceuticals GmbH, to gain insight on the newly developed AAV packaging system, allowing the helper virus-free stable production of AAV vectors without the need of a transient transfection step. Dr Faust will discuss:
- The challenges of AAV vector production – such as how using standard suspension cells for scale-up can result in relatively poor efficiency & reproducibility during transient transfection;
- Problems with current manufacturing methods, in particular when addressing more common diseases with gene therapy approaches, for example how with Alzheimer’s, Parkinson’s etc, bottlenecks in manufacturing arise during late stage clinical trials and when entering the market;
- How the CAP-GT platform can address scale-up challenges;
- Current AAV production platforms - different manufacturing systems have been developed for the large-scale production of AAV vectors for research, development, clinical evaluation and routine use for the treatment of rare diseases;
- Data on novel stable, helper virus-free CAP-GT platform – how growing cells in serum-free suspension culture at high densities can provide a fully scalable vector production platform.
Nicole Faust, CEO & CSO of CEVEC Pharmaceuticals GmbH
Dr. Nicole Faust has extensive management experience in the biotechnology sector. Over the last 18 years she has held scientific management positions with Artemis/Taconic Biosciences, amaxa, Lonza, and CEVEC, engaging in the fields of pharmaceutical models, gene transfer, protein production, and gene therapy. She received her Ph.D. from University of Freiburg and an MBA degree from Educatis University, Switzerland.