Abstract
The Chemistry, Manufacturing and Controls (CMC) section of a regulatory submission details aspects of the drug’s chemical properties, its manufacturing process development and production, and control mechanisms, including analytical testing both in-process and of the finished drug, to show the process is controlled and reproducible. For a candidate biosimilar much is already understood about the chemistry and properties of the drug by thorough characterization of reference drug product. The challenge is to develop a manufacturing process with adequate controls to ensure that the biosimilar product closely matches the reference drug product and to demonstrate this biosimilarity with a strong analytical package.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Bui LA, Hurst S, Finch GL, Ingram B, Jacobs IA, Kirchhoff CF, Ng C-K, Ryan AM. Key considerations in the preclinical development of biosimilars. Drug Discov Today. 2015;20(51):3–15.
Chaudhari PS, Nath R, Gupta SK. Opportunities and challenges in biosimilar development. Bioprocess Int. 2017;15(5):24–33.
Ghaderi D, Zhang M, Hurtado-Ziola N, Varki A. Production platforms for biotherapeutic glycoproteins. Occurrence, impact, and challenges of non-human sialylation. Biotechnol Genet Eng Rev. 2012;28:147–75.
Gray T. Biosimilar analytical similarity assessments: are you testing sufficient innovator lots? Biosimilar Dev. 2017. https://www.biosimilardevelopment.com/doc/biosimilar-analytical-similarity-assessments-are-you-testing-sufficient-innovator-lots-0001
Ha CY, Kornbluth A. A critical review of biosimilars in IBD: the confluence of biologic drug development, regulatory requirements, clinical outcomes and big business. Inflamm Bowel Dis. 2016;22(10):2513–26.
Müller-Späth T, Ulmer N, Aumann L, Bavand M. Twin-column cation-exchange chromatography for the purification of biomolecules. Biopharm Int. 2015;28(4):32–6.
Schiestl M, Stangler T, Torella C, Čepeljnk T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated pharmaceuticals. Nat Biotechnol. 2011;29(4):310–2.
Walsh G, Jefferis R. Post-translational modifications in the context of therapeutic proteins. Nature Biotech. 2006;24(10):1241--52.
Zhang T, Bourret J, Cano T. Isolation and characterization of therapeutic antibody charge variants using cation exchange displacement chromatography. J Chromatogr A. 2011;1218(31):5079–86.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2018 American Association of Pharmaceutical Scientists
About this chapter
Cite this chapter
Manzi, A.E., Ultee, M.E. (2018). Biosimilars Drug Substance Development and Manufacturing: Effective CMC Strategy. In: Gutka, H., Yang, H., Kakar, S. (eds) Biosimilars. AAPS Advances in the Pharmaceutical Sciences Series, vol 34. Springer, Cham. https://doi.org/10.1007/978-3-319-99680-6_8
Download citation
DOI: https://doi.org/10.1007/978-3-319-99680-6_8
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-99679-0
Online ISBN: 978-3-319-99680-6
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)