This will be the first presentation for the session "Essential Role of Excipients in Advancing Biological Drug Product".
Title: "Strategic Overview of Complex Excipients in US Pharmacopeia with a focus on polysorbates and LG polymers: Speaker: Otilia Koo, Chair of USP Complex Excipient Expert Committee, Executive director, Head of GPS Program Management, Global Product Development and Supply (GPS), Strategy and Business Excellence.
This presentation will cover the Science Quality Framework of USP that will advance the development of Complex Excipients Monographs including new monographs and modifications. The work on polysorbates and lactide & glycolide (LG, also called PLGA) within the Science Quality Framework will be presented to show the areas and examples of the progress. Future work and stakeholders' engagement will also be shared in the presentation.
Learning Objectives:
To acquire an understanding of the Science Quality Framework of US Pharmacopoeia (USP) to advance the development of Complex Excipients Monographs
Update on the lactide-glycolide (LG) polymer and polysorbates monographs development within the USP Complex Excipients Expert Committee 2020-2025 Workplan
Other updates and work conducted by the USP Excipients Collaborative Group including composition & impurities of excipients, nomenclature guidelines for excipients