In September, AMRI identified the deviation in one manufacturing suite as a result of a weather-related business interruption. The company said the remediation efforts have now been completed at the site, which features sterile filling of parenteral drugs using specialized technologies, including lyophilization.
The problems at the site, which was acquired in June as part of the $110m OsoBio deal, drove down the company’s latest quarterly profits.
AMRI CFO Michael Nolan told investors in the latest conference call that the site, a few weeks after it was acquired, “experienced a power failure that caused a PLC [programmable logic controller] malfunction…this allowed the doors to the aseptic core to remain open for a period of time. Backup power was available and after some remediation work at the facility was brought back online and production resumed.
“In early September, data monitoring signaled environmental deviations in one of the primary filling suites, and we determined that it was triggered by the power interruption and subsequent conditions,” Nolan said.
William Marth, AMRI's President and CEO, added: "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."
The OsoBio facility supports commercial scale production of liquid-filled and lyophilized parenterals. These services are provided for both small molecule drug products as well as biologics.
And as this facility has struggled in recent months, AMRI’s Burlington site has seen increasing demand for parenteral fill/finish work, with current customers looking to increase supplies, Nolan said on the conference call.