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.
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.
