Engage with regulators and industry experts about the challenges of immunogenicity assessment in biotherapeutics chemistry, manufacturing, and controls (CMC) at the USP Biologics Stakeholder Forum.
During this two-day virtual event, presenters and moderated panels will discuss immunogenicity risks associated with the development of protein and peptide drugs and the analytical techniques that support risk assessments. Within this broad topic, the forum will focus on immunogenicity test methods for both product-related immunogenicity and host cell protein impurities. The proceedings from the forum will support USP's development of new standards and industry consensus.
Standards enable manufacturers and regulators to facilitate comparability and tech transfer activities, and ultimately improve product quality and safety. Don't miss this opportunity to engage with USP, industry leaders, and regulators as we chart the course of industry best practices looking to the next generation of pharmacopeial standards.