Open for comment: US FDA confirms backing for continuous manufacturing and calls for industry input

By Flora Southey

- Last updated on GMT


Related tags Continuous manufacturing Food and drug administration

The US Food and Drug Administration (FDA) has called for drug industry feedback on continuous manufacturing.

The public docket, titled ‘Developing Continuous Manufacturing of Solid Dosage Drug Products in Pharmaceutical Manufacturing’ is open for electronic and written comments until September 21.

Doug Hausner, from the Centre for Structured Organic Particulate Systems’ (C-SOPS), told in-PharmaTechnologist the public docket shows that FDA support for continuous manufacturing has remained strong.

“As much as possible, without having some sort of specific policy, they ​[the FDA] are trying to work towards enabling continuous manufacturing,”​ he said.

A spokesperson for Johnson & Johnson (J&J) unit Janssen, which received FDA approval​ for a continuous production method for its HIV drug Prezista in 2016​, also observed that FDA backing for the approach had not diminished.

“While we cannot speak on behalf of the FDA, in 2015 Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research ​[CDER], urged companies to get on board with this new ​[continuous manufacturing] process when she spoke publicly in front of congress,” ​the spokesperson said.

Janssen’s work with Rutgers University Engineering School and the University of Puerto Rico on the development of continuous manufacturing also encouraged a partnership with the FDA, the Janssen representative told us.

The partnership, “helped create regulatory pathways for the use of continuous manufacturing in pharmaceutical production,”​ the spokesperson added.

The FDA leading by example?

When discussing the timing of the FDA’s public docket announcement, Hausner suggested the Administration’s recent push for the adoption of continuous manufacturing may relate to the International Conference on Harmonization (ICH)’s interest in the production method.

“At an ICH meeting last month, it was proposed that continuous manufacturing be considered as an ICH discussion point,” ​Hausner explained.

The suggestion was not taken on board, he told us.

“So it could be, that the FDA is recognising that while it can’t do everything, it can lead by example,” ​he said.

When we put this to the FDA, the spokesperson replied, “The FDA opened the docket to solicit feedback on papers and recommendations it had previously received.  ICH is still reviewing quality topic proposals and discussions are expected to continue at the Geneva meeting later this year.”

The FDA’s CDER spokesperson Jeremy Kahn told us the Administration is interested in hearing from stakeholders about the science, technology and practices discussed in an industry-coordinated best practices document​ on continuous manufacturing submitted by the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS), submitted in June 2016.

 The Administration also welcomes comment on control strategy, facility, and process validation for continuous manufacturing of solid oral dosage forms.

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