NIH suspends production at two facilities

NIH said it has suspended production at two facilities -- an NCI laboratory producing cell therapy products and a National Institute of Mental Health facility producing PET materials -- after independent firms found the facilities were not in compliance with quality and safety standards. NIH hired the firms to inspect all facilities producing sterile or infused products after manufacturing problems and compliance issues arose at the Pharmaceutical Development Section of NIH's Clinical Center (see BioCentury Extra, June 4, 2015).

NIH said there is no evidence that any patients have been harmed. On Monday, Kite Pharma Inc. (NASDAQ:KITE) said it paused enrollment in clinical studies conducted jointly with NCI while NIH reviews facilities involved with sterile material (see BioCentury Extra, April 18). ...