The Case for Orthogonal Aggregation Analysis

Orthogonal approaches to aggregation assessment



Are there more techniques to consider?

  1. ICH guideline Q6B: Note For Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (CPMP/ICH/365/96)
  2. Development of therapeutic protein biosimilars: Comparative analytical assessment of other quality-related considerations. Guidance for industry. FDA May 2019.
  3. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues (revision 1). EMA/CHMP/BWP/247713/2012, May 2014.