Continuous Manufacturing: Pfizer, Vertex, AstraZeneca and Others Weigh FDA Plans

Regulatory NewsRegulatory News | 04 October 2017 |  By 

The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology.


In contrast to batch manufacturing - where bulk materials are processed through multiple steps and subsequent batches must wait until the current batch is finished – continuous manufacturing allows companies to move more seamlessly and efficiently, though cost and other logistical challenges remain.

Last week, FDA finalized guidance on how manufacturers can participate in the agency’s program to advance continuous manufacturing and other emerging technologies.

And in a blog post, Michael Kopcha, director of FDA's Office of Pharmaceutical Quality, pointed to Vertex's cystic fibrosis drug Orkambi (lumacaftor/ivacaftor) and Janssen's HIV treatment Prezista (darunavir) as examples of companies successfully using continuous manufacturing after engaging with FDA's emerging technology team.

The comments from industry follow a May 2015 workshop during which FDA agreed that interested parties could submit for agency consideration draft guidance or other materials on the science, technology and best practices related to continuous manufacturing.


Generic drug industry group Association for Accessible Medicines noted that these barriers to implementing continuous manufacturing differ between brand and generic industries.

“For example, continuous manufacturing may provide significant advantages for products that are expected to have a long marketing lifecycle,” senior VP David Gaugh wrote. “However, for generic manufacturers, there is little certainty regarding the potential product lifecycle. As such, the necessary product development work to support continuous manufacturing may not be practical for some generic products.”

AAM’s comment also noted that generic manufacturers typically manufacture multiple products on a single line, which requires flexibility based on demand, “making adoption of certain technologies specific to a single product impractical. Also, some low volume products may be manufactured once or twice a year.”

In addition to the necessary investments not being justified for low-volume products, AAM also noted that many facilities with specialized processes are currently running at maximum capacity and the lead time and financial investment to expand capacity are significant.

Vertex Pharmaceuticals, which has adopted continuous manufacturing, noted several contradictions in how batch size is described in an FDA document and sought further clarity and certainty regarding FDA’s understanding and expectations regarding batch size.

AstraZeneca, meanwhile, asked if FDA might consider harmonizing the assessment process of the changes relating to continuous manufacturing, including a mechanism by which there could be some mutual recognition across countries participating in the International Council on Harmonization (ICH). AstraZeneca also said it “does not see the need” for a full ICH guideline on continuous manufacturing, which the company says FDA has been supporting. But the European drug industry group known as EFPIA is suggesting a Q&A document based on ICH Q8 and AstraZeneca says it “concurs with that approach.”

Similarly, Pfizer says that any further regulatory guidance on continuous manufacturing “would best be harmonized globally and targeted on specific topics, where general guidance provided in existing ICH guidance is not clear for CM applications (e.g. stability expectations, some aspects of GMP).”



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