High Potency API Maintaining Best Practices Through Continuous Improvement and Lessons Learned

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API

Oftentimes, the HPAPI sphere places the spotlight on manufacturing due to the containment challenges on large scale however; handling and containment strategies are also relevant in manufacture support roles such as chemical development, analytical, and process safety. In practice, these supporting roles are normally the first to handle highly potent material and can offer great insights into containment and engineering strategies for manufacturing. This is especially true in early phase programs where processes are not well defined and control strategies must be balanced with flexibility. This talk will discuss how AMRI engages its key stakeholders in the HPAPI arena and fosters an environment of risk mitigation and continuous improvement where worker safety is the common goal. It will also leverage AMRI’s 20+ years in HPAPI manufacturing through case studies highlighting lessons learned.

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