Drugs

FDAers Boost Viral Clearance in Continuous Manufacturing

FDA says CDER researchers have found three process steps to be important for promoting viral clearance during continuous manufacturing of therapeutic proteins. The researchers’ work follows their work to better understand how to remove viral particles during batch manufacturing of protein biologics using chromatographic, chemical inactivation, and filtration steps. An online post says continuous manufacturing is the next step in the evolution of therapeutic protein manufacturing and promises to increase efficiency through the immediate capture and purification of the target protein as it is produced in the bioreactor.

The three process steps identified by the researchers are capture chromatography, viral inactivation, and viral filtration.

The post says the integration of production and purification allows for shorter processing times, reduced manual intervention, and a reduction in facility size through the use of smaller tanks, bioreactors, and columns.

“Despite these advantages,” FDA says, “the individual unit operations as well as their connecting interfaces are different from those for batch mode processing, creating unique challenges in how viral safety and other risk-based approaches will be assured. CDER researchers collaborate with external stakeholders to investigate these unique challenges and their impact on viral safety.”

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