Evidence map›Paper›PMID 33666838›Full record

ArticlePharmaceutical research2021

Light-Induced Histidine Adducts to an IgG1 Molecule Via Oxidized Histidine Residue and the Potential Impact of Polysorbate-20 Concentration.

Ming Lei, Cynthia Quan, John Y Wang, Yung-Hsiang Kao, Christian Schöneich

Abstract read
PubMed Publisher
In one paragraph

Article in Pharmaceutical research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 26% 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

7 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Oxidation of polysorbates - An underestimated degradation pathway?International journal of pharmaceutics: X · 2023
    Review
  5. Article
  6. Article
  7. Review
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

5 authors at 3 institutions in 2 countries.

Ming LeiProtein Analytical Chemistry, Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA. lei.ming@gene.com.ORCID http://orcid.org/0000-0002-1247-1358
Cynthia QuanProtein Analytical Chemistry, Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.
John Y WangLate Stage Pharmaceutical Development, Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.
Yung-Hsiang KaoProtein Analytical Chemistry, Genentech, Inc., 1 DNA Way, South San Francisco, California, 94080, USA.
Christian SchöneichDepartment of Pharmaceutical Chemistry, University of Kansas, 2095 Constant Avenue, Lawrence, Kansas, 66047, USA. schoneic@ku.edu.
Gene Therapy Laboratory · FRPharmaceutical Product Development (United States) · USUniversity of Kansas · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeHistidine (His) undergoes light-induced reactions such as oxidation, crosslinking and addition. These reactions are initiated by singlet oxygen (

resultsWe identified and characterized light-induced His-adducts of mAb-1 by LC-MS/MS. We showed that the levels of light-induced His-adducts generally correlate with the solvent accessibility of His residues in the protein. In addition, the presence of PS-20 at concentrations commonly used in protein drug formulations can significantly increase the levels of light-induced His-adducts.

conclusionsSince His residues are present in a conserved region in the Fc domain, and may be present in the complementarity-determining region (CDR), the impact on the biological functions of the His-adducts observed here should be further studied to evaluate the risk of their presence.

Indexed as

Amino Acid SequenceChromatography, High Pressure LiquidDrug CompoundingExcipientsHistidineImmunoglobulin GOxidants, PhotochemicalOxidation-ReductionPolysorbatesProtein AggregatesProtein ConformationProtein DenaturationTandem Mass SpectrometryExcipientsHistidineImmunoglobulin GOxidants, PhotochemicalPolysorbatesProtein AggregatesHistidineIgGlight stressoxidationpolysorbate-20solvent accessibility

Identifiers

PMID33666838
OpenAlexW3135212758

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.