Evidence map›Paper›PMID 26305772›Full record

ArticlemAbs2015

Rapid quantitative analysis of monoclonal antibody heavy and light chain charge heterogeneity.

Ram P Vanam, Michael A Schneider, Michael S Marlow

Open access · goldAbstract read
In one paragraph

Article in mAbs, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Ram P Vanama Pre-Clinical Development and Protein Chemistry, Regeneron Pharmaceuticals, Inc. ; Tarrytown , NY USA.
Michael A Schneidera Pre-Clinical Development and Protein Chemistry, Regeneron Pharmaceuticals, Inc. ; Tarrytown , NY USA.
Michael S Marlowa Pre-Clinical Development and Protein Chemistry, Regeneron Pharmaceuticals, Inc. ; Tarrytown , NY USA.
Mental Health Association of Westchester County · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

An alternative method to traditional 2-dimensional gel electrophoresis (2D-PAGE) and its application in characterizing the inherent charge heterogeneity of chromatographically isolated monoclonal antibody heavy and light chains is described. This method, referred to as ChromiCE, utilizes analytical size-exclusion chromatography (SEC), performed under reducing and denaturing conditions, followed by imaged capillary isoelectric focusing (icIEF) of the chromatographically separated heavy and light chains. Under conditions suitable for the subsequent icIEF analysis, the absolute and relative SEC elution volumes of the heavy and light chains were found to be highly pH dependent, a phenomenon that can be exploited in optimizing chromatographic separation. Compared to 2D-PAGE, the ChromiCE method substantially decreases the time and labor needed to complete the analysis, improves reproducibility, and provides fully quantitative assessment of charge heterogeneity. The ChromiCE methodology was applied to a set of diverse monoclonal antibodies to demonstrate suitability for quantitative charge variant analysis of heavy and light chains. A typical application of ChromiCE in extended characterization and stability studies of a purified antibody is shown.

Indexed as

Antibodies, MonoclonalChromatography, GelElectrophoresis, Gel, Two-DimensionalHumansHydrogen-Ion ConcentrationImmunoglobulin Heavy ChainsImmunoglobulin Light ChainsIsoelectric FocusingProtein DenaturationReproducibility of ResultsTime FactorsAntibodies, MonoclonalImmunoglobulin Heavy ChainsImmunoglobulin Light Chainscharge variantsdeamidationdenatured chromatographyisoelectric focusingmonoclonal antibodyreducedstability 2D-PAGE

Identifiers

PMID26305772
PMCPMC4966340
OpenAlexW2142553884

What OpenQuestion holds

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Registered trials

None linked

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.