Lilly confident in remediating troubled COVID mAb plant

Eli Lilly has engaged an external firm to conduct a comprehensive independent review after the FDA found data integrity issues at a manufacturing facility in New Jersey.

Earlier this month, Reuters broke the news that the US Food and Drug Administration (FDA) issued Eli Lilly’s Branchburg, New Jersey manufacturing site with an “Official Action Indicated” (OAI) notice. This came after an inspection in November last year found that processing data had been deleted and not appropriately reviewed by the firm’s quality unit.

During Lilly’s third quarter results call this week, CEO Dave Ricks spoke frankly about the inspection:

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“Late last year, our Branchburg plant underwent a routine FDA general surveillance inspection. The inspectors identified findings related to data handling and we received an official action indicated notice, as well as a follow up inspection this year. We have not received a warning letter or other enforcement letter from the FDA at this time,” he told stakeholders.

The Branchburg site manufactures a number of products for Eli Lilly, including bamlanivimab (LY-CoV555) a monoclonal antibody Lilly is developing as both a monotherapy and a combination therapy against COVID-19.

“We are confident the issues raised during the inspections did not impact product quality or patient safety for bamlanivimab or for any other product manufactured at the Branchburg plant,” Ricks said.

“Having said that, we and I take remediation of these data handling issues and our commitment to quality and safety very seriously,” he continued:

“We engaged an external firm to conduct a comprehensive independent review of systems at the Branchburg site, and we were working diligently to incorporate suggestions for improvement to our procedures.

“We have also had this firm perform independent reviews of our manufacturing of bamlanivimab at Branchburg to examine our manufacturing batch records and quality documentation to corroborate our own batch release decisions as we submit for supply of bamlanivimab from Branchburg for the emergency use authorization we requested. We are confident in the material at this facility and frankly at all of our sites.”

He added Lilly’s COVID-19 neutralizing antibodies are made across a global network, with five drug substance sites worldwide in addition to five additional drug product sites. As well as inhouse production, Lilly has contracted both Fujifilm Diosynth Biotechnologies and Amgen as third-party manufacturers.