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

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.

• Strategies for maintaining best practices in HPAPI development and manufacturing
• Identifying risk potential early in development
• Integration of process safety studies into HP space
• Case studies involving tech transfer from HP development to HP manufacturing suites and lessons learned.

Speaker

Andrew Leyhane, Ph.D., Senior Research Scientist II, AMRI

Andy earned his Ph.D. from Boston College in 2008 working under the guidance of Prof. Marc Snapper.  He subsequently joined AMRI where he’s held positions in Medicinal Chemistry, Small Scale Manufacturing, and Chemical Development.  Since 2013, he has managed AMRI’s non-GMP high potency Suites and is routinely involved in the tech transfer of HPAPIs to our cGMP facilities.

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