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NIH Closes Two Clinical Facilities for Sterility Issues

National Cancer Institute

National Cancer Institute in Rockville, Maryland (NIH, Flickr)

20 April 2016. National Institutes of Health closed two of its clinical facilities found not in compliance with safety and quality standards that could put patients at risk. Facilities at NIH closed for not meeting Current Good Manufacturing Practice standards are a cell therapy production lab at National Cancer Institute and a production center for positron emission tomography or PET scanning materials.

NIH says the closures made public yesterday are a result of an interim report from two companies hired to review all operations at the agency making sterile or infusion products used by participants in clinical trials. The review was conducted after NIH’s own inspections of the Pharmaceutical Development Section in its Clinical Center in April 2015 revealed vials of albumin, a protein in blood serum administered with the cell-signaling protein interleukin, with fungal contamination.

A follow-up inspection by the U.S. Food and Drug Administration in May 2015 found several deficiencies in the Clinical Center’s pharmacies: lack of protective apparel to prevent contamination of drugs, deficient control systems for sterile conditions in clean rooms, deficient systems for cleaning and maintaining clean room sterile conditions, and lack of clearly defined areas for drug compounding operations that risked contamination or mix-ups.

The cell therapy section at National Cancer Institute is testing cancer treatments that use engineered T-cells from a patient’s own immune system. Kite Pharma in Santa Monica, California, has a number of research agreements with NCI assessing the company’s technology producing special receptors on the surface of T-cells called chimeric antigen receptors that attract antigens for fighting cancer. Kite Pharma says in a statement that closing of the cell therapy section affects work with NCI, but none of its other clinical trials, including those testing its lead product.

In December 2015, NIH director Francis Collins formed a separate working group, known as the Red Team, to evaluate the organization, financing, and management of the Clinical Center and its affiliated labs and production facilities. The Red Team’s mandate included an examination of …

structural and cultural issues at the Clinical Center that may have contributed to the deficiencies identified in the Pharmacy and Pharmaceutical Development Service, and review other research activities at the Clinical Center that pose a potential risk to research participants.

The group is expected to make its first report tomorrow.

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