Abstract
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 in a pre-competitive space, 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, humanized IgG1κ Reference Material 8671 (RM 8671), has been established with the intent of filling that void. The NISTmAb embodies the quality and characteristics of a typical biopharmaceutical product, is widely available to the biopharmaceutical community, and is an open innovation tool for development and dissemination of results. The NISTmAb lifecyle management plan described herein provides a hierarchical strategy for maintenance of quality over time through rigorous method qualification detailed in additional submissions in the current publication series. The NISTmAb RM 8671 is a representative monoclonal antibody material and provides a means to continually evaluate current best practices, promote innovative approaches, and inform regulatory paradigms as technology advances.Graphical abstractThe NISTmAb Reference Material (RM) 8671 is intended to be an industry standard monoclonal antibody for pre-competitive harmonization of best practices and designing next generation characterization technologies for identity, quality, and stability testing.
Highlights
Monoclonal antibodies increasingly dominate the biopharmaceutical market, boasting an unparalleled diversity of indications such as cancer, hyperlipidemia, and autoimmune disorders [1]
The physicochemical evaluation methods were applied to three lots of NIST monoclonal antibody (NISTmAb) Reference Material 8671 (RM 8671) to evaluate homogeneity, stability and assign lot-specific reference values as reported on the Report of Investigation available with the material and described in detail in publication 5 of this series [15, 49]. This analysis was performed while bracketing with the instrument qualification (IQ) standard specific to each method and primary sample 8670 (PS 8670) to ensure system suitability; effectively qualifying each Reference Material (RM) 8671 lot as fit-for-purpose
The approach taken for informational value assignment utilized many of the same measurement principles as described for the qualified physicochemical assays; Instrument system suitability criteria were established using an appropriate IQ standard, methods were optimized for PS 8670, and repeatability/intermediate precision assessment was performed [17]
Summary
Monoclonal antibodies increasingly dominate the biopharmaceutical market, boasting an unparalleled (and growing) diversity of indications such as cancer, hyperlipidemia, and autoimmune disorders [1]. In 2013, nearly 10 metric tons of monoclonal antibody were manufactured to supply nearly $75 billion in global sales [2]. Under the Quality by Design (QbD) paradigm, comprehensive physicochemical and biophysical characterization of product quality attributes (PQAs) provides.
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