At a recent meeting in Boston, representatives from global pharmaceutical companies gathered to discuss how to transition from batch to continuous manufacturing. And, what company best to learn from than Vertex Pharmaceuticals, the first company to produce a drug on a continuous processing line that was approved by the Food & Drug Administration (FDA).
Stephanie Krogmeier, Vertex’s senior director of global regulatory chemistry, manufacturing and controls (CMC) strategy, was the keynote speaker at the Commercializing Continuous Processing in Pharma conference. She used the opportunity to share some “lessons learned” from their continuous manufacturing (CM) conversion, especially as it relates to dealing with the FDA.
