Health regulators advise companies developing cell and gene therapy products to gather as much information early on in product development as possible and to build on this knowledge as these therapies progress through the pipeline from research to commercialization. Having this information early on leads to high-quality, consistent products that can be correlated to safety and efficacy.
Regulators discussed some of the complexities involved in manufacturing cell and gene therapy products and how to surmount these challenges at a July 17-18 meeting on cell and gene therapies...