USP Standards to Support the Characterization of mAbs: Applications and General Chapter 129

Are you interested in the analytical development of monoclonal antibodies (mAbs)? USP Biologics presents a webinar with case studies and supporting data to help you navigate through the analytical procedures used to evaluate the quality attributes of mAbs for therapeutic use.

Register Free: https://www.biopharminternational.com/bp_w/standards-to-support

Event Overview:

The development of monoclonal antibodies (mAbs) is marked by impurities such as host cell proteins and residual DNA. USP offers solutions to evaluate the quality attributes of mAbs for therapeutic use.

Join this webinar to learn more about the validated methods that are described in USP–NF General Chapter <129> Analytical Procedures For Recombinant Therapeutic Monoclonal Antibodies, which include purity determination by size-exclusion chromatography (SEC), capillary electrophoresis, and analysis of glycans. Analytical procedures for mAbs using SEC-UHPLC and its inclusion in chapter <129> and the multi-attribute method (MAM) are also reviewed and demonstrated through case studies, and USP’s solutions to detect process-related impurities are discussed.

Key Learning Objectives:

• Identify procedures used for evaluation of quality attributes of therapeutic mAbs included in USP–NF General Chapter <129> and other chapters.
• Understand USP solutions for the detection of product- and process-related impurities for mAbs.
• Explain how the USP Reference Standards and materials can be used to assess system suitability, or be applied as a tool for analytical method development.

Who Should Attend:

• QA/QC Analysts
• Regulatory Professionals
• Biochemists
• R&D Scientists and Managers
• Manufacturing Scientists and Managers
• Contract Research/Manufacturing Organizations

Speakers:

Niomi Peckham
Director of Pipeline Development, Global Biologics
United States Pharmacopeia

Niomi Peckham is Director of Pipeline Development in USP Global Biologics. The Pipeline Development team works with scientific experts and stakeholders to develop physical and documentary standards used to support development and quality assessment of biopharmaceuticals.

Ms Peckham has worked for several biotechnology and diagnostic companies but has spent most of her career at Pfizer and Alexion Pharmaceuticals, focusing on development of protein-based biopharmaceuticals. She has been responsible for development, validation, transfer, and lifecycle management of analytical methods for biopharmaceuticals from pre-clinical development through commercialization. She has had a particular focus on analysis of monoclonal antibodies and host cell proteins.

Ms Peckham holds a Bachelor of Science in Biotechnology from the University of Connecticut, a Master of Science in Molecular and Cellular Biology from SUNY Stony Brook, and a Graduate Certificate in Drug Development from Temple University.

Li Jing
Principal Scientist, Global Biologics
United States Pharmacopeia

Dr Li Jing is a Senior Manager in USP’s Global Biologics Department. Dr. Jing leads a team of liaisons working with the USP Expert Committees and multiple expert panels for proteins, peptides, and carbohydrates to develop standards that support biopharmaceutical quality assessment and development. Recently, Dr Jing worked with USP MAM Expert Panel and developed General Chapter <1060> Mass Spectrometry Based Multi-Attribute Method for Therapeutic Proteins.

Dr Jing holds a PhD in Analytical Chemistry from the University of Georgia, and a Bachelor of Science in Chemistry from Fudan University. She has worked for several biotechnology and pharmaceutical companies, focusing on the development of protein therapeutics and vaccine candidates.

Register Free: https://www.biopharminternational.com/bp_w/standards-to-support