This course explains why measurement of charge variants is important. It will also describe multiple techniques (i.e., ion exchange chromatography, cIEF/icIEF) commonly used to measure changes in biologics during development, production and stability testing and why they are often CQAs. Best practices for development of methods are included as well as data generated with USP’s new monoclonal antibody Reference Standards. The pros and cons of various orthogonal approaches along with troubleshooting common issues will be discussed.

Subject area:
Biologics

Objectives (If applicable):
• State the USP standards that support measurements of critical quality attributes in biologics and particularly monoclonal antibody therapeutics.
• Describe methods used to measure charge variants in biologics.
• Explain how to interpret the resulting data from these methods.
• Describe how the resulting data from these methods can be used to support the quality and stability assurance of biologics.

Target Audience (If applicable):
Compendial Liaison
Consultant
Engineering/Manufacturing Staff
QA Manager
QA Staff
QC Chemist
QC Manager
R&D Staff
Regulatory Staff
Student, CMOs, CROs