After an 'environmental deviation' in one manufacturing suite that was discovered in September
US contract research and manufacturing organisation AMRI has resumed full manufacturing operations at its sterile injectables facility in Albuquerque, New Mexico after an 'environmental deviation' in one of the manufacturing suites was identified in September.
The company said the problem had been caused by a 'weather-related business interruption' and the resulting remediation work has now been completed.
William Marth, AMRI's President and Chief Executive, said: 'We are pleased to report that all suites at our OsoBio Albuquerque aseptic manufacturing facility are fully operational. I would like to acknowledge and thank our colleagues and vendors for their dedicated efforts in remediating the affected manufacturing suite as quickly as possible.'
AMRI's OsoBio facility in New Mexico provides cGMP manufacturing and sterile filling of parenteral drugs using specialised technologies, including lyophilisation. With its cGMP aseptic filling expertise, OsoBio supports commercial scale production of liquid-filled and lyophilised parenterals. These services are provided for both small molecule drug products as well as biologicals.
AMRI acquired Oso Biopharmaceutical Manufacturing in July this year for US$110m. The company manufactures complex injectable drug products and AMRI said its expertise in large-scale commercial production complemented AMRI’s early stage drug product manufacturing capabilities.