NIH Shuts Down Two Facilities In Contamination Probe
This article was originally published in Scrip
The National Institutes of Health (NIH) on April 19 acknowledged that an ongoing investigation into contamination at its sterile production facilities has resulted in the shutdown of two of those operations – declaring they were not in compliance with quality and safety standards.
The facilities involved are a laboratory at the National Cancer Institute (NCI), which was engaged in cell therapy production, and a facility at the National Institute of Mental Health, which was producing positron emission tomography materials.
The NIH had launched its investigation last summer after FDA inspectors identified serious problems, including spore-forming organisms, such as Cladosporium and Aspergillus midulans, in two vials of albumin human serum made at its Clinical Center Pharmaceutical Development Section.
The NIH had hired two companies specializing in quality assurance for manufacturing and compounding – Working Buildings and Clinical IQ – to evaluate all of the agency's facilities producing sterile or infused products for administration to research participants.
No new patients are being enrolled in affected trials until the issues are resolved.
The NIH insisted there was no evidence that any patients have been harmed.
Nonetheless, it said a rigorous clinical review would be undertaken.
The NIH's admission comes three days after Kite Pharma Inc. issued a statement revealing cell therapy manufacturing facilities at the NCI were undergoing a voluntary internal review.
Kite and the NCI are advancing multiple clinical trials under cooperative research and development agreements for the treatment of both hematological and solid tumors.
Lion Biotechnologies Inc., which also is developing products with the NCI, also issued a statement, which came on April 17, about the NIH's review of its facilities.