Chair(s): Mitra Mosharraf

Speaker(s): Patrick Lim Soo,   Jeffrey Clogston

This webinar is a joint collaboration with the International Consortium for Innovation and Quality in Pharmaceutical Development (About Us)  and specifically with the IQ Consortium Nanomaterial and Nanotechnology Working Group. The consortium is made up of 50+ member companies and their employees.

Nanomedicine drug products have reached an unprecedented high in terms of global commercial acceptance and media exposure with the approvals of the mRNA COVID-19 vaccines in 2021. We examine the current state of the art for nanomedicine technologies as applied for pharmaceutical products and compare those with industry trends. We find that 1) industry companies continue to push the envelope in terms of new technologies for characterizing their specific drug products, 2) new analytical technologies continue to be utilized by industry to characterize the increasingly complex nanomedicine drug products and 3) alignment and communication are key between industry and regulatory authorities to better understand the regulatory filings that are being submitted. There are many CMC challenges that a company must overcome to successfully file a nanomedicine drug product. We propose a complimentary guide providing knowledge on specific CMC issues such as quality attributes, physicochemical characterization methods, excipients, and stability.