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Case Study – Amgen Meets Regulatory Requirement via Field-to-Lab Methodology

The Challenge

  • Amgen is the world’s largest independent biotechnology firm. In August 2011, Amgen had twelve approved drugs or therapeutic biologicals.
  • Their products are susceptible to damage from vibration and shock input. They ship in a temperature‐controlled supply chain (cold chain).
  • Amgen needed to quantify their shipping environment and then simulate those conditions in the lab.

Red blood cells.

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Amgen vibration test chamber.

The Solution

  • Amgen utilized Lansmont’s Field‐to‐Lab philosophy and our expert services to develop their own testing procedures.
  • Vibration tests are performed at measured levels (not accelerated) and conducted inside an environmental chamber.

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