Accelerated clinical trial timelines for advanced therapeutics are on the rise. With Fast Track status designations, it is increasingly critical for innovators to have efficient and scalable production processes.
Explore case studies for neuromuscular degenerative indications, AAV technology and manufacturing, and strategies for navigating the regulatory environments in the U.S. and Europe.
While the first autologous cell therapy commercial products have shown tremendous clinical success, scaling out these therapies while considering individual patient processes is a new challenge.
The success of using viral vectors to deliver a molecular payload into a cell or replace defective genes with functional ones is an inflection point in the future of modern medicine.