Along with the complexities of vaccine and viral-based gene therapy process development comes the need for analytical techniques that can help assess quality parameters, especially in real time.
In this review we discuss a few attributes that should be considered when planning manufacturing at scale for your cell therapy.
Explore case studies for neuromuscular degenerative indications, AAV technology and manufacturing, and strategies for navigating the regulatory environments in the U.S. and Europe.
The gene therapy clinical pipeline is in a high-growth phase, with an influx of venture capital funding. There are also challenges: scalability, dosing, and the price of the final treatment.