Gene therapy aims to provide cures for life-threatening diseases that currently rely on complex and expensive life-long medications presenting a significant opportunity for companies to help people to live better lives. Although the quest for a templated process to speed up in the race to commercialization has largely remained elusive, we are starting to see evidence of scientific data from the process development experts.
Midstream unit operations consist of steps such as cell lysis, DNA digestion and clarification. These are considered gold-standard unit operations in Adeno Associated Virus (AAV) production processes. Optimization of this midstream set of unit operations use should a mandatory step in process development. Collaborations between technology providers and gene therapy companies are critical in establishing know-how and solving the toughest challenges in gene therapy manufacturing. An example of a fruitful partnership between MilliporeSigma/Merck and Precision BioSciences in developing an integrated approach to an AAV harvest step will be presented in this webinar.