Biologics

‘High Throughput Sequencing’ Can be Standardized: FDA Research

Results of a study led by FDA scientists suggest that a new technology known as high throughput sequencing (HTS) could be standardized and used for rapid screening of biologic products, including vaccines, to demonstrate absence of contamination. The technology reportedly enables scientists to sequence hundreds of millions of DNA molecules at a time.

An agency statement says the study results support development of standard reference virus reagents that can be used to validate the performance of their HTS procedures to demonstrate absence of viral contamination for product safety.

“To determine if HTS could producer reliably similar screening results in difference laboratories, scientists at FDA and in two other industry laboratories each independently used the technique to determine how well it could detect four model viruses…. The viruses were spiked into a human cell line called HeLa, using disrupted whole cell material or RNA extracted from the cells to represent potential types of samples that are tested for adventitious viruses in biologics (microorganisms that may have been unintentionally introduced into the manufacturing process of a biological medicinal product),” FDA says. “The results showed that regardless of the commercial gene analysis device used or the preparation techniques used to perform the screening processes, the results were comparable among the laboratories. That is, the laboratories identified about the same amount of each virus in the samples regardless of the differences in sample preparation and processing. This finding supports the future development of reference virus materials that could be used to standardize their HTS methodologies and validate their findings.”

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