The NIST Biomanufacturing Program develops measurement science, standards, reference data and tools to support the development, manufacturing, and regulatory approval of biologic medicines. Lifecycle appropriate application of current and emerging techniques requires rigorous testing followed by discussion between industry and regulators, an effort facilitated by widely available test metrics. Biopharmaceutical quality materials, however, are often difficult to access and/or are protected by intellectual property rights. The NISTmAb IgG1k 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. The utility of the NISTmAb as an industry-wide test metric to evaluate performance of emerging technologies, foster collaboration, and spur innovation will also be discussed.
1. Familiarization with the NIST monoclonal antibody (NISTmAb) and its utility in advancing biopharmaceutical analytics
2. Gain knowledge about the many applications of multi-attribute mass spectrometry methods and opportunities/challenges facing implementation into QC.