Several sessions at yesterday’s INTERPHEX conference in New York addressed continuous processing and continuous manufacturing. Perspectives from FDA, industry (including Pfizer Global Manufacturing), and academia were presented.

The overall feeling seems to be that batch processing is on its way out and that initiatives such as PAT, QbD, and the new FDA process validation guidance are leading to continuous manufacturing (CM) across industry. Said FDA’s Francis Godwin within DMPQ, “numbers are irrelevant now, it’s all about what you know” about the product and process. Speakers addressed some of the key challenges that come with CM such as scale up and a lack of state-of-the-art equipment for certain processes. But they also talked about the many advantages, such as reducing a company’s footprint and costs. The fact that CM has been used in the food industry for decades helps as well (i.e., regulators know what to look for in certain processses and pharma can borrow from food).

Some questions that are still being worked out include how FDA is going to define a batch versus a lot (the CFR regulations include some verbage), how recalls may be handled with a CM batch or lot, and how to most effectively clean a CM system with regard to startup and shutdown time. FDA’s Moheb Nasr, head of ONDQA within CDER, said that FDA supports CM and that there are no regulations preventing its practice. He advised that companies interested in starting a CM approach call FDA to schedule a discussion to be sure that all parties are on the same page before implementation.