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. 2018 Mar;410(8):2067-2078.
doi: 10.1007/s00216-017-0844-2. Epub 2018 Feb 12.

The NISTmAb Reference Material 8671 lifecycle management and quality plan

John E Schiel  1 , Abigail Turner  2   3
Affiliations

The NISTmAb Reference Material 8671 lifecycle management and quality plan

John E Schiel et al. Anal Bioanal Chem. 2018 Mar.

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 abstract The 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.

Keywords: Biopharmaceutical; Biosimilar; Biotherapeutic; Monoclonal antibody; NISTmAb; Reference material; System suitability.

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Conflict of interest statement

Conflict of interest

The authors declare that they have no conflict of interest.

Disclaimer

Values reported herein were collected during NISTmAb qualification and/or value assignment and are current at the time of publication. Users should always refer to the Report of Investigation (https://www-s.nist.gov/srmors/view_detail.cfm?srm=8671) for their specific material lot for the most up to date values and uncertainty ranges. Certain commercial equipment, instruments, or materials are identified to adequately specify the experimental procedure. Such identification does not imply recommendation or endorsement by the National Institute of Standards and Technology, nor does it imply that the materials or equipment identified are necessarily the best available for the purpose.

Figures

Graphical abstract
Graphical abstract
The 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.
Fig. 1
Fig. 1
Representative lifecycle management plan employed by the biopharmaceutical industry that incorporates a two-tier reference standard. Solid arrows represent use of a material for a specific purpose. Dashed red arrow represents a working reference standard qualification exercise and dashed blue arrows represent lot release
Fig. 2
Fig. 2
Lifecycle management plan for NISTmAb RM 8671. Solid arrows represent use of material to mix, vial, dilute, etc. Dashed gray arrow represents a value assignment exercise
See this image and copyright information in PMC

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