Biologics

Regulatory Review Didn’t Slow Covid Vaccines: Marks

Keynoting the International Society for Pharmaceutical Engineering 2022 Biotechnology Conference, CBER director Peter Marks said regulatory pathways and review were not the biggest rate-limiting factor in Covid-19 vaccine development. Rather, he said, the real bottleneck was process development and manufacturing scaleup, as reported by Bioprocess Online.

Under Operation Warp Speed, Marks said, manufacturing development took place concurrent with condensed Phase 1, 2, and 3 trials. Thus, as soon as data indicated that a vaccine might have the potential to provide an immune response, manufacturing scale-up started and at the end of Phase 3 trials, millions of doses were ready to ship.

Marks said that while the doses would have been destroyed if not found to be safe and effective, that would have been a small price to pay for the ability to have something available.

Even in an expedited approach, Marks said, there were bottlenecks, including:

issues in securing sufficient raw materials;
a dearth of disposable supplies;
limited bioreactor capacity;
a shortage of well-trained professionals to operate the available bioreactor capacity; and
limited fill/finish capacity.

The lessons learned during Operation Warp Speed have accelerated the transition to continuous or semi-continuous production to enable agility, flexibility, reliability, and reproducibility in biologics manufacturing, Marks said.

“The advantage of moving in this direction is that we could potentially have our vaccine supply more easily ramped up on short notice,” he said.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome