Speaker Spotlight: Emerging Standards and Iterative Approaches to Novel Excipients

Spotlight Speaker(s)

• 

  Jenny Liu, PhD (she/her/hers)

  Senior Principal Scientist • Science-Excipients
  USP
  Rockville, Maryland

Moderator(s)

• 

  Jiaying Liu, PhD (she/her/hers)

  Associate Principal Scientist
  Merck & Co., Inc.
  Rahway, New Jersey

Novel excipients play a pivotal role in enhancing drug stability, bioavailability, and therapeutic efficacy in pharmaceutical formulations. However, their selection, characterization, and regulatory compliance present unique challenges for drug manufacturers. This session provides an in-depth exploration of the complexities surrounding novel excipients, equipping participants with the knowledge and tools necessary to navigate this evolving landscape.

Insights into the critical role of novel excipients in drug development, as well as the regulatory requirements and quality control practices essential for ensuring product compliance and patient safety. The presentation will also highlight emerging standards related to novel excipients development, focusing on USP's efforts to develop and refine these standards through the establishment of an Expert Panel and revisions to General Chapter <1074> Excipient Biological Safety Evaluation Guidelines.

Throughout the session, participants will discover the challenges and benefits of incorporating novel excipients into their formulations, while gaining insights into USP's iterative approaches and emerging standards and possible pathways, such as analytical reference materials, application notes, general chapters, etc., that may help remove the current barriers to using novel excipients in new therapeutics and advanced formulations.

By understanding the impact of these standards on elevating industry practices and ensuring the highest levels of quality, safety, and efficacy in pharmaceutical products, attendees will be better prepared to navigate the complexities of novel excipients and drive innovation in their organizations.