Midstream unit operations: unsung heroes in AAV process development

Although the quest for a templated process to accelerate the race to commercialization for cell and gene therapies has largely remained elusive, we are starting to see scientific data from process development experts. One underappreciated area of process development is midstream unit operations, which consist of steps such as cell lysis, DNA digestion, and clarification. Here, an example of a fruitful collaboration between Merck and Precision BioSciences to develop an integrated approach to an adeno-associated virus (AAV) harvest step will be presented, with key takeaways that can be implemented in everyday process development.

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