Webinar: Changes to Sub-visible Particle Regulations for Parenteral Biopharmaceuticals

Learning Objectives

• How new regulatory guidelines for injected protein therapeutics address gaps in prior USP <788> for sub-visible particles (2-10 microns, >10 microns).
• Strategies to apply the new criteria in formulation development, manufacturing, and quality control
• Use of Flow Imaging analysis for sensitive detection of sub-visible particles, including protein aggregates at >2 microns

Overview

Current Pharmacopeial guidelines for monitoring subvisible particulates (SVPs) in therapeutic protein injections have expanded into new areas as USP <787> is provided as an alternative to <USP 788>. How will these new regulations impact your particle monitoring approaches? Join us for a webinar presentation by Dr. Satish K. Singh to learn more about these new guidelines and their impact.

During the follow-up discussion moderated by Angelica Olcott, real-world examples will exemplify how orthogonal techniques such as flow imaging have been implemented for sensitive detection of sub-visible particles.

Speaker

Satish Singh, Ph.D., Research Fellow, Group Leader Department of Biotherapeutics Pharmaceutical Sciences, Pfizer