Evidence map›Paper›PMID 36151884›Full record

ArticlemAbs

Physicochemical and biological impact of metal-catalyzed oxidation of IgG1 monoclonal antibodies and antibody-drug conjugates via reactive oxygen species.

Zephania Kwong Glover, Aaron Wecksler, Baikuntha Aryal, Shrenik Mehta, Melissa Pegues, Wayman Chan, Mari Lehtimaki, Allen Luo, Alavattam Sreedhara, V Ashutosh Rao

Open access · goldAbstract read
In one paragraph

Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.0field-weighted citation impact, top 8% 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

12 citing papers in PubMed, 26 citations in OpenAlex.

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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

10 authors at 1 institution in 1 country.

Zephania Kwong GloverPharmaceutical Development, Genentech Inc, South San Francisco, CA, USA.
Aaron WeckslerAnalytical Development, Genentech Inc, South San Francisco, CA, USA.
Baikuntha AryalLaboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Maryland, USA.
Shrenik MehtaPharmaceutical Development, Genentech Inc, South San Francisco, CA, USA.
Melissa PeguesLaboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Maryland, USA.
Wayman ChanPharmaceutical Development, Genentech Inc, South San Francisco, CA, USA.
Mari LehtimakiLaboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Maryland, USA.
Allen LuoBiological Technologies, Genentech Inc, South San Francisco, CA, USA.
Alavattam SreedharaPharmaceutical Development, Genentech Inc, South San Francisco, CA, USA.
V Ashutosh RaoLaboratory of Applied Biochemistry, Division of Biotechnology Research and Review III, Office of Biotechnology Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administrations, Maryland, USA.ORCID 0000-0001-6817-8049
Center for Drug Evaluation and Research · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Biotherapeutics are exposed to common transition metal ions such as Cu(II) and Fe(II) during manufacturing processes and storage. IgG1 biotherapeutics are vulnerable to reactive oxygen species (ROS) generated via the metal-catalyzed oxidation reactions. Exposure to these metal ions can lead to potential changes to structure and function, ultimately influencing efficacy, potency, and potential immunogenicity of the molecules. Here, we stress four biotherapeutics of the IgG1 subclass (trastuzumab, trastuzumab emtansine, anti-NaPi2b, and anti-NaPi2b-vc-MMAE) with two common pharmaceutically relevant metal-induced oxidizing systems, Cu(II)/ ascorbic acid and Fe(II)/ H

Indexed as

Antineoplastic Agents, ImmunologicalImmunoconjugatesAdo-Trastuzumab EmtansineAntibodies, MonoclonalAscorbic AcidCatalysisDithiothreitolFerrous CompoundsHydrogen PeroxideImmunoglobulin GMyosinsOxidation-ReductionProtein CReactive Oxygen SpeciesTrastuzumabAdo-Trastuzumab EmtansineAntibodies, MonoclonalAntineoplastic Agents, ImmunologicalAscorbic AcidDithiothreitolFerrous CompoundsHydrogen PeroxideImmunoconjugatesImmunoglobulin GMyosinsProtein CReactive Oxygen SpeciesTrastuzumabantibody drug conjugate (ADC)carbonylationcoppercu(II)fe(II)fragmentationhingehydroxy radical foot printingironmAb IgG1metal bindingoxidationreactive oxygen species (ROS)SPR

Identifiers

PMID36151884
PMCPMC9519010
OpenAlexW4297154598

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.