Drugs

CDER Researchers Looking at Protein Chemical Changes

Researchers in CDER’s Office of Biotechnology Products (OBP) are studying chemical reactions that occur in therapeutic protein products and can have a significant impact on protein function. CDER laboratory of biochemistry chief V. Ashutosh Rao writes in a Spotlight on CDER Science post that the chemical reactions are of great interest because they can directly affect the quality, safety, and efficacy of protein products.

He says that OBP laboratory researchers have published important new information about protein carbonylation, which entails the addition of a single atom of oxygen, originating from the environment, to discrete carbon atoms within protein molecules. “Although protein carbonylation has been recognized within the context of disease and age-related conditions,” Rao writes, “its occurrence during the manufacture, storage, use, and transport of therapeutic proteins is a relatively new area of study.”

The post says the researchers’ findings may help protein drug developers produce therapeutic proteins under optimized manufacturing conditions, potentially with structural alterations or by adding stabilizing additives that could prevent harmful carbonylation reactions. More stable protein drugs, it says, could offer a longer shelf life, reduced risk of quality problems, and more predictable clinical performance.

“Understanding reactions such as protein carbonylation may result in improved versions of current drugs or new drugs with superior stability, purity, and potency,” Rao concludes. “Above all, the goal is to have safe and effective high-quality protein products available for patients.”

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