From Clinical Production to Commercial Manufacturing in ATMP Facilities
Nov 19, 2019
Peter Walters’ “The Pain-Free Guide: Transitioning from Clinical Production to Commercial Manufacturing” was featured in Contract Pharma. The article discusses how cell and gene therapy facilities face a unique set of challenges as they scale towards commercial production and require equally unique solutions.
“As the first few advanced therapy medicinal products (ATMPs) gain regulatory approval, and as patients with previously incurable diseases find new reasons to hope for effective treatment, the pressure to move quickly can bear down with enormous force. Across every biopharmaceutical area, the years spent progressing through preclinical and clinical studies are years of colossal pre-profit spending. That slender window between the first day of commercial manufacturing and the last day of a patent’s term of protection is often a company’s first and only opportunity to slingshot themselves back into the black. Getting there as soon as possible, while maintaining regulatory compliance and ensuring the safety and care of the patient population, is a central preoccupation.”