Noel Maestre, advanced therapy medicinal product (ATMP) director at CRB guides readers through the steps needed to implement manufacturing strategies for advanced medicines.
Strategies
It’s a thrilling time to be part of an advanced therapy medicinal product (ATMP) project. You’re working on a new frontier of scientific discovery, using some of the fastest-evolving and most complex techniques available to potentially cure our most malignant diseases. For patients and drug developers alike, ATMP manufacturing could be a dream come true.
Unfortunately, turning that dream into reality is infinitely challenging. A frontier, by nature, has no roadmap. It’s uncharted territory, which means one thing: Risk. Every company in the race towards commercial ATMP production knows this. First, there’s the risk of not moving fast enough, which could cost you your position in the marketplace. Then there’s the opposite and equally menacing risk of moving too fast, betting your success on unproven process equipment technology in a Good Manufacturing Practice (GMP) environment. Then, adding further pressure to the shoulders of ATMP manufacturers, is the debate currently raging over the high cost of these curative therapies.