Meeting Regulatory Assay Guidelines When Developing Therapeutic Antibodies

Guidelines for Analytical Assay Development and Validation

The process of developing therapeutic antibodies is inherently complex, making it necessary to have strict regulations governing the design process. These guidelines provide crucial guidance on appropriate testing strategies and regulatory expectations for validating analytical assays, which are ultimately crucial in ensuring product safety.

Read this article to gain insight into:

• Expectations from the U.S. Federal Drug and Food Administration and European Medicines Agency for therapeutic antibody development
• Common challenges associated at each stage of the antibody development process
• Tips for meeting regulatory guidelines and recommendations for designing validated analytical methods