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Mobilizing Manufacturing: Portable and Point of Care Manufacture of Medicines
Session Chair(s)
Celeste Frankenfeld Lamm
Senior Director, Global Regulatory Affairs – CMC
Merck Sharp & Dohme LLC , United States
What if we could put wheels on a pharmaceutical manufacturing site and move it right to the point of patient treatment? What if we could right-size manufacture for small volume, or personalized treatments? What if we could replicate identical manufacturing units to rapidly respond to increasing volume demand, and then repurpose those units as demand decreased? We might be able to both speed important medicines to patients, and reduce the risks that are associated with a typical manufacturing site move. The technology exists to enable portable and point of care manufacturing, but the regulatory framework can present challenges. As we move to facilitate portable manufacturing, it is important to understand the regulatory challenges, and also opportunities. This session will discuss the benefits, regulatory challenges, and opportunities for implementation of portable and point of care manufacturing of medicines.
Learning Objective : List the benefits of and opportunities for portable manufacturing; Identify regulatory challenges to implementation of portable manufacturing; Discuss strategies to meet regulatory expectations.
Speaker(s)
MHRA Update
Ian Rees, DVM, MBA
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Expert Inspector, GMP/GDP
Challenges and Opportunities in Distributed Manufacturing
Dr. Joel Welch
US FDA, United States
Deputy Office Director, OPQA III, OPQ, CDER
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