The NISTmAb Reference Material 8671 Lifecycle Management and Quality Control Strategy
John E. Schiel, Abigail Turner
Comprehensive analysis of monoclonal antibody therapeutics involves an ever expanding cadre of technologies. Lifecycle appropriate application of current and emerging techniques requires rigorous testing followed by discussion between industry and regulators, an effort that may be facilitated by a widely available test metric. Biopharmaceutical quality materials, however, are often difficult to access and/or are protected by intellectual property rights. The NISTmAb IgG1κ is a NIST Reference Material (RM 8671) intended to fill that void. The NISTmAb embodies the quality and characteristics of a biopharmaceutical product, is widely available to the biopharmaceutical community, and is an open innovation tool for development and dissemination of results. A comparative summary of biopharmaceutical industry-related standards is accompanied herein by an overview of the NISTmAb lifecycle management plan, modeled closely after biopharmaceutical industry best practices. The overview provides a hierarchical strategy for both assurance and maintenance of quality over time through rigorous method qualification, detailed in additional submissions in the current publication series.
and Turner, A.
The NISTmAb Reference Material 8671 Lifecycle Management and Quality Control Strategy, mAbs, [online], https://doi.org/10.1007/s00216-017-0844-2
(Accessed June 2, 2023)