Register Here Agenda Speaker Bios Event Presentations
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.
Event Presentations
- In Vitro Assays: Perspectives for Innovators and Generics - Andrew Graves, Teva
- Assessing Immunogenicity Risk of Peptide Drugs using IVISIA: Generic Drug Perspective - Eric Pang, FDA, CDER
- T Cell Assay Harmonization Efforts Using HESI Standard Material - Laurent Malherbe, Lilly (HESI)
- Immunogenicity of Bio-Therapeutics: Advances in systems based predictive analytics - Narendra Chirmule, Symphony Technology
- Host Cell Protein Related Immunogenicity Risk Assessment Strategies - Vibha Jawa, Epivax
- In vitro, In vivo, and In clinic impact of Attributes - Ahmed Elbaradei, Amgen
- PLBL2 and Immunogenic HCPs - Christina de Zafra, Pfizer
For questions, please contact:
Bruno De Carvalho (bruno.decarvalho@usp.org)