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Monoclonal Antibody Therapeutics: The Need for Biopharmaceutical Reference Materials

Published

Author(s)

John E. Schiel, Anthony Mire-Sluis, Darryl Davis

Abstract

The use of naturally derived substances for therapeutic use has a longstanding history of success. Therapeutic monoclonal antibodies can be thought of in a similar light as they harness the highly evolved specificity of adaptive immunity to fight disease. Monoclonal antibody-based therapeutics have grown exponentially with the advent of mammalian cell culture, process, and formulation technology. At the same time, state-of-the-art and emerging analytical and biophysical methodology provides very detailed process and product information. While such a battery of methodology and wealth of information is critical to product understanding; the accuracy, precision, robustness, and suitability of such techniques are also of critical importance. Performance specifications have previously been set on a product specific basis, and continued suitability verified with trending and comparability to in-house product specific reference standards. This mechanism is likely irreplaceable due to the highly individual, yet heterogeneous nature of mAb therapeutics. However, a representative and widely available material along with detailed historical data would greatly supplement characterization efforts throughout the drug product lifecycle. To this end, a first-of-its kind qualitative and quantitative biopharmaceutical Reference Material to supplement drug substance/product characterization is described. The NIST mAb IgG1κ is intended to provide a well characterized, longitudinally available test material that is expected to greatly facilitate development of originator and follow-on biologics for the foreseeable future.
Citation
Current, State of the Art, and Emerging Technologies for the Analysis of Monoclonal Antibodies
Volume
1176
Publisher Info
American Chemical Society, Washington DC, DC

Citation

Schiel, J. , Mire-Sluis, A. and Davis, D. (2014), Monoclonal Antibody Therapeutics: The Need for Biopharmaceutical Reference Materials, Current, State of the Art, and Emerging Technologies for the Analysis of Monoclonal Antibodies, American Chemical Society, Washington DC, DC, [online], https://doi.org/10.1021/bk-2014-1176.ch001 (Accessed February 25, 2024)
Created December 16, 2014, Updated November 10, 2018