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The NISTmAb Reference Material 8671 lifecycle management and quality plan.

John E Schiel1, Abigail Turner2,3

  • 1National Institute of Standards and Technology, Institute for Bioscience and Biotechnology Research, 9600 Gudelsky Dr, Rockville, MD, 20850, USA. john.schiel@nist.gov.

Analytical and Bioanalytical Chemistry
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PubMed
Summary

The National Institute of Standards and Technology Monoclonal Antibody (NISTmAb) Reference Material 8671 provides a widely accessible, industry-standard material. This enables harmonization of best practices and development of advanced characterization technologies for antibody therapeutics.

Keywords:
BiopharmaceuticalBiosimilarBiotherapeuticMonoclonal antibodyNISTmAbReference materialSystem suitability

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Area of Science:

  • Biotechnology
  • Analytical Chemistry
  • Regulatory Science

Background:

  • Monoclonal antibody (mAb) therapeutics analysis requires advanced technologies, necessitating standardized materials for method development and validation.
  • Access to high-quality biopharmaceutical materials for research is often limited due to cost and intellectual property restrictions.
  • Harmonizing testing methodologies between industry and regulatory bodies is crucial for efficient therapeutic development.

Purpose of the Study:

  • To introduce the NISTmAb Reference Material 8671 as a widely available, industry-standard material for mAb characterization.
  • To facilitate pre-competitive collaboration and the development of next-generation analytical technologies.
  • To support the rigorous evaluation of current best practices and inform regulatory approaches for mAb therapeutics.

Main Methods:

  • Establishment and characterization of NISTmAb RM 8671 as a representative humanized IgG1κ antibody.
  • Development of a hierarchical lifecycle management plan for maintaining RM 8671 quality over time.
  • Method qualification strategies detailed for ensuring the reliability of analytical data.

Main Results:

  • NISTmAb RM 8671 is characterized to embody typical biopharmaceutical product quality.
  • The reference material serves as an open innovation tool for the biopharmaceutical community.
  • A framework for ongoing quality assessment and method validation is established.

Conclusions:

  • NISTmAb RM 8671 is a vital resource for advancing the analytical characterization of monoclonal antibodies.
  • It promotes the harmonization of identity, quality, and stability testing methodologies.
  • This reference material supports the evolution of regulatory science and therapeutic development through standardized evaluation.