1. Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
2. European Medicines Agency (2014), “Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Quality Issues (Revision 1).”
3. FDA, CBER, CDER (2019), “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations” (Draft guidance).
4. International Conference on Harmonization (2004), “Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process.”