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From Batch to Continuous Manufacturing

Lessons learned from Vertex Pharmaceuticals on strategy, technology and working with regulatory officials to get an FDA-approved drug.

From Batch to Continuous Manufacturing
From Batch to Continuous Manufacturing

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 better to learn from than Vertex Pharmaceuticals, the first company to produce a drug on a continuous processing line that was approved by the Food and 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 relating to the FDA.

While most people in the room were just beginning their CM journey, she made it clear to her peers that such a complex project will not happen—or be a success—without buy-in from the C-suite.

“You need the full support of management. If you don’t have someone in senior management driving this, you will fail,” Krogmeier said. “On top of that you need a team of smart and dedicated people working on this. And having a great molecule is hugely important. If you know you are getting a fantastic molecule to the market, it motivates the team.”
 

Vertex built its CM line from the ground up for a cystic fibrosis drug called Orkambi (lumacaftor/ivacaftor). During the planning and deployment of the production line, the control strategy was a critical part of the plan, Krogmeier said, outlining the use of process analytical technology (PAT) for in-process control (IPC) and real-time release testing (RTRT). But just as important was a sharp focus on the FDA and the European Medicines Agency (EMA) criteria.

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