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

Aug 10th, 2011

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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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See related stories:

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Drug Industry Survey Reveals Wide Disparity in Approaches to Controlling Glass Quality

Sharp Uptick in Recalls for Glass Lamellae Problems Under Scrutiny

The series of IPQ stories, which comprises an in-depth report on the current challenges and solutions to glass control for injectable products, can be purchased for $295 by contacting Wayne Rhodes ([email protected]qpubs.com).  Individual stories can be purchased for $95 each.

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