Monoclonal Antibody Therapeutics: The Need for Biopharmaceutical Reference Materials
John E. Schiel, Anthony Mire-Sluis, Darryl Davis
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.
Current, State of the Art, and Emerging Technologies for the Analysis of Monoclonal Antibodies
, Mire-Sluis, A.
and Davis, D.
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)