QC in ATMP production: Sailing a stormy sea, what’s the key?

Medicines based on genes, cells, or tissue engineering, i.e. Advanced Therapy Medicinal Products (ATMPs) are a rising star shining brighter and brighter in the horizon for any CDMO operating in life-science. It is natural that many reconsider strategies and set a new course toward this brand-new reality. However, it is neither an easy destination to get to, nor is the route smooth sailing. Rough seas are expected as each manufacturer bear the responsibility to put in place appropriate measures ensuring the quality of these unique products is maintained and simultaneously comply with the GMP prerequisites, and all under extremely strict timelines.