The NIH announced it had ceased production at a National Cancer Institute lab and a National Institute of Mental Health facility yesterday, explaining the move was prompted by assessments of the sites by contractors, Working Buildings and Clinical IQ.
“This evaluation is underway and preliminary findings have identified facilities not in compliance with quality and safety standards, and not suitable for the production of sterile or infused products.
“As a result, production has been suspended in two facilities: a National Cancer Institute laboratory engaged in cell therapy production and a National Institute of Mental Health facility producing positron emission tomography (PET) materials.”
The NIH hired Working Buildings and Clinical IQ to assess all its labs last year after US Food and Drug Administration (FDA) inspectors discovered serious breaches of manufacturing rules at facilities operated by its Pharmaceutical Development Section (PDS).
An NIH spokeswoman told us the contractors "specialize in quality assurance for manufacturing and compounding who are conducting uniform evaluations across all of NIH’s facilities producing sterile and infused products and will develop remediation plans."
She added the organisations "identified non-compliance with quality assurance and regulatory standards in the physical facilities.
The NIH also made clear “there is no evidence that any patients have been harmed, but a rigorous clinical review will be undertaken."
The organisation added that it will not enrol patients in clinical trials of the cell therapy products until the review is completed.
The National Cancer Institute site had been working with Santa Monica, California-based developer Kite Pharma.
According to a company statement "Kite and the NCI are advancing multiple clinical trials under Cooperative Research and Development Agreements (CRADAs) for the treatment of both hematological and solid tumors.
"Patients currently enrolled in the ongoing NCI clinical trials will receive therapy, but no new patients will be enrolled until the review is complete. The NCI's ongoing clinical trial of a fully human anti-CD19 chimeric antigen receptor (CAR)-based product candidate is not affected by the review."
The firm also stressed that: "The review of the NCI's manufacturing facilities is not related to KTE-C19 or Kite's manufacturing capabilities."
According to Clinicaltrials.gov all KTE-19 are currently recruiting.