Continuous or batch? A quality question

Doug Hausner from the Centre for Structured Organic Particulate Systems (C-SOPS) said he thought the FDA was backing continuous manufacturing for two reasons: quality and transparency.

“There is the perception, that with continuous manufacturing, you can achieve higher quality,”​ Hausner told us.

He also said he thought the FDA was backing the continuous production approach for its transparency, which according to Hausner, makes mistakes easier to spot than in batch manufacturing.

“One of the big challenges in batch manufacturing is when things go wrong. It is challenging trying to truly establish, from a scientific perspective, whether your corrections will have an effect,” ​he said.

A spokesperson for Johnson & Johnson’s (J&J) unit Janssen, which received FDA approval​ for a continuous manufacturing production method for its HIV drug Prezista in 2016​, told in-PharmaTechnologist the benefits of continuous manufacturing are varied.  

“Although it is not easy for drug manufacturers to transition from batch to continuous manufacturing, the rewards of implementation are widespread," ​said the spokesperson.

"It is likely that we will see increased investment in continuous manufacturing in drug development and production of commercialised medicines,”​ they told us.

Industry input for guidelines​

Last week the FDA opened a public docket​ to discuss issues surrounding the adoption of continuous manufacturing.

Hausner said he thought the FDA was requesting submissions in order to release guidance material, and consequently facilitate the adoption of continuous manufacturing.

“To some extent, the FDA is trying to crowdsource information, and more importantly, to make sure it has some form of consensus among the industry, in order to move forward with guidance elements,” ​he told us.