Cell and gene therapies have been in development for decades, but they’ve only recently been approved by regulatory authorities such as the FDA. That’s because the science has moved forward to a place where it’s safe and effective for patients.
To achieve rapid clinical and commercial success, a bench process must be scalable and suitable for a manufacturing environment — and that means chemistry, manufacturing and controls (CMC) must be lined up. Most innovators don’t have the regulatory experience to know what manufacturing changes are going to make a difference early on. Biotech founders share their experiences and advice here.