Process Platforms Vs. Custom Process Development For AAVs And Gene Therapies

By Avi Nandi, VP, Process Development, Center for Breakthrough Medicines

Gene therapies hold huge promise for patients with a range of monogenic diseases and unmet medical needs, but they’ve had their fair share of safety concerns. Dosing and delivery have been the sources of recent setbacks. Efficient, scalable, and cost-effective manufacturing is another hurdle the industry needs to overcome before commercially viable therapies can be licensed. AAV technology advances are also needed to address yield, material costs, and cycle times in a bid to bring down COGS and ultimately increase financial accessibility by global patient populations.

To address issues of cost, time to market and manufacturing complexity, many developers have turned to turnkey manufacturing platforms. The question is whether these platforms provide the right solution for successful CMC development.

In this article, explore a comparison of process platforms and custom development. See how to mitigate process control risks and offset the time and cost of custom development.