Monoclonal Antibody Size Variant Characterization by Size Exclusion Chromatography: From Compendial to New Methods for Quality Attribute Analysis

Join experts from USP and Tosoh Bioscience for an in-depth seminar on compendial size exclusion chromatography (SEC) methods for monoclonal antibody analysis, featuring insights into USP chapter requirements, reference standard materials, and practical implementation strategies. Learn how pairing USP-qualified reagents with high-performance SEC columns can help improve method performance, reproducibility, and confidence for monoclonal antibody characterization.

Register Free: https://www.chromatographyonline.com/lcgc_w/variant

Event Overview:

Analytical liquid chromatography, particularly ultrahigh- and high-performance liquid chromatography (U)HPLC, play a central role in the characterization of therapeutic monoclonal antibodies (mAbs). (U)HPLC workflows enable detailed examination of a broad matrix of critical quality attributes, including size variants (e.g., aggregates, fragments), charge variants, and posttranslational modifications that can influence potency, stability, and safety.

When applied across development and manufacturing life cycles, these chromatographic techniques are key to ensuring product quality during development and commercial analysis, as well as analytical comparability during biosimilar development. In this webinar, USP and Tosoh will discuss both standardization of (U)HPLC methods for quantitative mAb analysis, the role of USP reference standards in demonstrating analytical method performance, and how Tosoh Bioscience’s size-exclusion chromatography platforms support robust, in-depth mAb characterization suitable for discovery, development, and manufacturing applications.

Key Learning Objectives:

• Understand fundamentals of size-exclusion chromatography and its application to antibody analysis
• Explore how compendial methods simplify assessment of method performance for SEC
• Recognize nuances that distinguish sample degradation from column degradation

Who Should Attend:

• Scientists, senior scientists, analytical chemists, method validation scientists, QC scientists, chromatography, R&D
• Pharmaceutical employees, life science employees, instrument manufacturers, university instructors/professors

Speakers:

Niomi Peckham, M.S.
Director, Pipeline Development
United States Pharmacopeia

Niomi Peckham, M.S., is the director of pipeline development in USP Global Biologics. The pipeline development team works with scientific experts and stakeholders to develop physical and documentary standards that support the development and quality assessment of biopharmaceuticals. She holds a master of science degree in molecular and cellular biology from Stony Brook University. Peckham has spent most of her career at Pfizer and Alexion Pharmaceuticals, focusing on analytical development of protein-based biopharmaceuticals from preclinical through commercial development.

Jonas Wege, M.S.
Head of Global Application Development
Tosoh Bioscience

Jonas Wege, M.S., graduated from Karlsruhe Institute of Technology (Germany) with a major in biotechnology and biopharmaceutical process engineering, holding bachelor’s and master’s degrees in bioengineering. Wege now leads the application development team at Tosoh Bioscience, which focuses on developing chromatographic purification processes and analytical methods using Tosoh’s process resins, HPLC columns, and instruments.

Register Free: https://www.chromatographyonline.com/lcgc_w/variant