Evidence map›Paper›PMID 31560789›Full record

ArticleElectrophoresis2019

Application of affinity capillary electrophoresis for charge heterogeneity profiling of biopharmaceuticals.

Andrei Hutanu, Steffen Kiessig, Andrea Bathke, Rolf Ketterer, Sonja Riner, Jan Olaf Stracke, Markus Wild, Bernd Moritz

Abstract read
In one paragraph

Article in Electrophoresis, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. 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

8 authors.

Andrei HutanuF. Hoffmann-La Roche Ltd, Basel, Switzerland.ORCID 0000-0003-0174-5250
Steffen KiessigF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Andrea BathkeF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Rolf KettererF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Sonja RinerF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Jan Olaf StrackeF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Markus WildF. Hoffmann-La Roche Ltd, Basel, Switzerland.
Bernd MoritzF. Hoffmann-La Roche Ltd, Basel, Switzerland.ORCID 0000-0001-9116-1878

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Charge heterogeneity profiling is important for the quality control (QC) of biopharmaceuticals. Because of the increasing complexity of these therapeutic entities [1], the development of alternative analytical techniques is needed. In this work, flow-through partial-filling affinity capillary electrophoresis (FTPFACE) has been established as a method for the analysis of a mixture of two similar monoclonal antibodies (mAbs). The addition of a specific ligand results in the complexation of one mAb in the co-formulation, thus changing its migration time in the electric field. This allows the characterization of the charged variants of the non-shifted mAb without interferences. Adsorption of proteins to the inner capillary wall has been circumvented by rinsing with guanidine hydrochloride before each injection. The presented FTPFACE approach requires only very small amounts of ligands and provides complete comparability with a standard CZE of a single mAb.

Indexed as

Antibodies, MonoclonalBiological ProductsElectrophoresis, CapillaryAntibodies, MonoclonalBiological ProductsAffinity capillary electrophoresisCharge heterogeneity testingFlow-through partial fillingMonoclonal antibody co-formulation

Identifiers

PMID31560789
PMCPMC6900010

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Registered trials

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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.