Amgen Glass Lamellae Investigation Sheds Light on Biopharma’s Control Challenges and Solutions

Amgen’s extensive investigation into the glass lamellae problems it experienced with Epogen, which has included the development of characterization techniques, narrowing down of causal factors, and evaluation of glass manufacturing processes, sheds new light on biopharma’s glass control challenges and the approaches to addressing them.

Amgen shared the insights it has gained from its investigations and corrective and preventive follow-up actions at a two-day PDA/FDA “Glass Quality Conference” in late May in Arlington, Virginia, and a one-day “Glass Container Delamination Scientific Symposium” sponsored by the pharmaceutical supply chain consortium Rx-360, held the following day at the same location.

The range of the Amgen presentations at the meetings speaks to the depth of its investigations and the breadth of the glass-related control challenges that biotech manufacturers face during a product’s lifecycle.

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