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FDA Perspective: COVID-19 Learnings in Communication, Manufacturing

Dr. Peter Marks: “One thing we definitely learned does not work: you can't keep cold capacity. If you have a facility that's completely cold… then you want to try to bring it up to manufacture vaccines, it just doesn't work well.”

Dr. Peter Marks, MD, PhD, director, CBER, FDA.
Dr. Peter Marks, MD, PhD, director, CBER, FDA.

Marking its in-person return after three years, the 31st  PDA/FDA Joint Regulatory Conference in Washington D.C. opened with perspective from FDA on COVID-19 challenges, key learnings, and best practices coming out of the pandemic. To illustrate progress, many products that moved forward through emergency use authorizations (EUAs) are now maturing into full drug applications including biologics license applications (BLAs).

“We may be a little bit slower to emerge because we're still under the weight of a fair amount of COVID-19 work,” said Dr. Peter Marks, MD, PhD, director, CBER, FDA. “Despite the fact that things are getting a bit more back to normal right now for everyone, we very much have to keep in the back of our minds that we still have this threat of recurrence or of further evolution of this in the background.”

Challenges

One major challenge Marks highlighted was the issue of facilitating an adequate amount of quality manufacturing capacity. “That became very apparent within several months of the beginning of the pandemic. We've also had to deal with the issue of early access to medical products and the natural tension that occurs when you have an unmet medical need, and want to get things to people in need, and yet still have to offer assurance that they are safe and that they work,” he explained. The agency is also focusing on optimizing operations with a partially remote workforce.

Traditionally vaccine development is a highly de-risked process—it proceeds from stage to stage via the traditional phases of development, 1, 2, and 3. Often, the manufacturing scale-up doesn't occur until late in the process. It’s not worth it to develop capacity before it’s clear the candidate will actually become a commercial entity.

But during a pandemic when a vaccine is badly needed, companies might want to take risks in terms of scaling up manufacturing earlier, as happened at the outset of COVID-19 with Operation Warp Speed. Clinical trials were essentially condensed and as soon as there was clear demonstration of immunogenicity and some degree of safety from these vaccines, manufacturing scale-up started—and not just scale-up, but production of tens of millions of doses.

“There were also a lot of bottlenecks that were countered, not just in vaccine manufacturing but throughout the industry. I know because for a period towards the beginning of the pandemic for about the first six to nine months, I was involved in trying to help direct some of the traffic of plastic wear, etc.,” said Marks. There were cases where companies were running out pipette tips which had the potential to affect blood supply by hamstringing blood testing, and 500-liter bioreactor bags were also under threat. “We started to have issues with raw materials… disposable supplies particularly. We didn't have enough bioreactor capacity. And not only did we not have enough bioreactor capacity, but we didn't have enough people who knew how to run those bioreactors in a quality manner to be able to bring things up to capacity. We certainly didn't have enough fill/finish capacity. [We realized] we're going to have all these doses of vaccines and we don't have enough vials to put them in and we don't have enough facilities to put them in vials.”


Read article   Read this story on FDA discussing quality management maturity (QMM).


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