Thursday, May 21st, 2020

The current manufacturing processes for viral vectors for gene therapy, which we can define as Gene Therapy Manufacturing 1.0 (e.g., adherent cell culture and transient expression from plasmid transfection), are not productive enough to meet the future demand considering the quickly increasing number of approved gene therapies and clinical trials. A transition is therefore ongoing to implement more productive and scalable processes, leading to Gene Therapy Manufacturing 2.0 using suspension cell culture and developing producer cell lines. Adopting the right technology solutions on this journey is essential.

In this talk we will:

  • Evaluate the near-future needs for gene therapy manufacturing

  • Discuss the major technology challenges posed to quickly develop high-productivity, -safety, and -quality manufacturing processes for viral vectors

  • Propose technology solutions for upstream (perfusion cell culture) and downstream (tangential-flow filtration and chromatography) processing to overcome these challenges.

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