ArticleAnalytical and bioanalytical chemistry2018
Development of orthogonal NISTmAb size heterogeneity control methods.
Article in Analytical and bioanalytical chemistry, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
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Who cites it
16 citing papers in PubMed.
- A novelmAbs · 2025Article
- NIST Biomanufacturing Reference Materials: Development, Applications, and Impact.Bridge (Washington, D.C. : 1969) · 2025Article
- Ligand-Bound Forced Degradation as a Strategy to Generate Functionally Relevant Analytical Challenge Materials for Assessment of CQAs.Frontiers in molecular biosciences · 2022Article
- Interlaboratory Studies Using the NISTmAb to Advance Biopharmaceutical Structural Analytics.Frontiers in molecular biosciences · 2022Review
- Characterization and Value Assignment of a Monoclonal Antibody Reference Material, NMIJ RM 6208a, AIST-MAB.Frontiers in molecular biosciences · 2022Article
- Site-specific glycan-conjugated NISTmAb antibody drug conjugate mimetics: synthesis, characterization, and utility.Analytical and bioanalytical chemistry · 2021Article
- Atomic Model Structure of the NIST Monoclonal Antibody (NISTmAb) Reference Material.Journal of research of the National Institute of Standards and Technology · 2021Article
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- A rapid and quantitative technique for assessing IgG monomeric purity, calibrated with the NISTmAb reference material.Analytical and bioanalytical chemistry · 2019Article
- The NISTmAb Reference Material 8671 lifecycle management and quality plan.Analytical and bioanalytical chemistry · 2018Article
- Development of an LC-MS/MS peptide mapping protocol for the NISTmAb.Analytical and bioanalytical chemistry · 2018Article
- The NISTmAb Reference Material 8671 value assignment, homogeneity, and stability.Analytical and bioanalytical chemistry · 2018Article
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- NS0 and CHO cell lines generate distinct quality profiles for non-originator NISTmAbs.Biotechnology progressArticle
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Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The NISTmAb is a monoclonal antibody Reference Material from the National Institute of Standards and Technology; it is a class-representative IgG1κ intended to serve as a pre-competitive platform for harmonization and technology development in the biopharmaceutical industry. The publication series of which this paper is a part describes NIST's overall control strategy to ensure NISTmAb quality and availability over its lifecycle. In this paper, the development of a control strategy for monitoring NISTmAb size heterogeneity is described. Optimization and qualification of size heterogeneity measurement spanning a broad size range are described, including capillary electrophoresis-sodium dodecyl sulfate (CE-SDS), size exclusion chromatography (SEC), dynamic light scattering (DLS), and flow imaging analysis. This paper is intended to provide relevant details of NIST's size heterogeneity control strategy to facilitate implementation of the NISTmAb as a test molecule in the end user's laboratory. Graphical abstract Representative size exclusion chromatogram of the NIST monoclonal antibody (NISTmAb). The NISTmAb is a publicly available research tool intended to facilitate advancement of biopharmaceutical analytics. HMW = high molecular weight (trimer and dimer), LMW = low molecular weight (2 fragment peaks). Peak labeled buffer is void volume of the column from L-histidine background buffer.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.