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The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability.

John E Schiel1, Abby Turner2,3, Trina Mouchahoir2

  • 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
|February 8, 2018
PubMed
Summary
This summary is machine-generated.

NISTmAb Reference Material (RM) 8671 establishes an industry standard for monoclonal antibody characterization. This ensures consistent quality and supports the development of advanced testing technologies for biopharmaceuticals.

Keywords:
BiopharmaceuticalBiosimilarBiotherapeuticMonoclonal antibodyNISTmAbReference MaterialSystem suitability

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Area of Science:

  • Biopharmaceutical characterization
  • Analytical chemistry
  • Biophysics

Background:

  • Monoclonal antibodies (mAbs) are critical biopharmaceuticals.
  • Standardized reference materials are needed for quality control and technology development.
  • NISTmAb Reference Material (RM) 8671 aims to fulfill this need.

Purpose of the Study:

  • To establish NISTmAb RM 8671 as an industry standard for monoclonal antibody characterization.
  • To ensure long-term availability and consistent product quality.
  • To support harmonization of best practices and development of next-generation characterization technologies.

Main Methods:

  • Stratified sampling and analysis plan.
  • Utilized qualified analytical and biophysical methods.
  • Analyzed in conjunction with primary sample 8670 (PS 8670).

Main Results:

  • RM 8671 demonstrates consistent material attributes (size, charge, identity) across multiple lots.
  • Verified homogeneity within and between vialing lots.
  • Confirmed RM 8671's suitability as a technology innovation tool and external control.

Conclusions:

  • NISTmAb RM 8671 meets criteria for an industry standard monoclonal antibody reference material.
  • The lifecycle management plan ensures material robustness and consistency.
  • RM 8671 is fit for purpose in advancing biopharmaceutical characterization and quality control.