Tips to Ensure Product Comparability in Gene Therapy
Tips to Ensure Product Comparability in Gene Therapy Source: D-Keine/Getty Images Why is it important to study how manufacturing changes affect product quality? Heidaran: Gene therapies are complex, and the product is largely defined by the process, which means minor changes could potentially cause major changes in quality and efficacy. Development timelines are also quite compressed. Whereas you might have a 10- to 15-year development program for a small molecule or biologic, you can get some advanced therapies approved in around five years. There’s also quite a bit of process change invo...
Source: genengnews.com