Evidence map›Paper›PMID 37798537›Full record

ArticlePharmaceutical research2023

Application of NMR and Chemometric Analyses to Better Understand the Quality Attributes in pH and Thermally Degraded Monoclonal Antibodies.

Victor A Beaumont, Lucy Liu, Heliang Shi, Jason C Rouse, Hai-Young Kim

Open access · hybridAbstract read
In one paragraph

Article in Pharmaceutical research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 24% 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

5 citing papers in PubMed, 6 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

5 authors at 1 institution in 2 countries.

Victor A BeaumontPfizer, Inc. BioTherapeutics Pharmaceutical Sciences, Analytical Research and Development, 1 Burtt Road, Andover, MA, 01810, USA. victor.beaumont@pfizer.com.ORCID http://orcid.org/0000-0001-9626-0111
Lucy LiuPfizer, Inc. BioTherapeutics Pharmaceutical Sciences, Analytical Research and Development, 1 Burtt Road, Andover, MA, 01810, USA.
Heliang ShiPfizer, Inc. Global Product Development, Oncology & Rare Disease Statistics, New York City, NY, 10001, USA.
Jason C RousePfizer, Inc. BioTherapeutics Pharmaceutical Sciences, Analytical Research and Development, 1 Burtt Road, Andover, MA, 01810, USA.
Hai-Young KimPfizer, Inc. BioTherapeutics Pharmaceutical Sciences, Analytical Research and Development, 1 Burtt Road, Andover, MA, 01810, USA. hai-young.kim@pfizer.com.
Pfizer (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeNuclear magnetic resonance (NMR) spectroscopy provides the sensitivity and specificity to probe the higher order structure (HOS) of monoclonal antibodies (mAbs) for potential changes. This study demonstrates an application of chemometric tools to measure differences in the NMR spectra of mAbs after forced degradation relative to the respective unstressed starting materials.

methodsSamples of adalimumab (Humira, ADL-REF) and trastuzumab (Herceptin, TRA-REF) were incubated in three buffer-pH conditions at 40°C for 4 weeks to compare to a control sample that was left unstressed. Replicate 1D

resultsVisual and statistical inspection of the 2D

conclusionThe chemometric analyses support the lack of statistical differences in the structure of pH-thermal stressed adalimumab, however, it reveals conformational changes or chemical modifications in trastuzumab after forced degradation. Application of chemometrics in comparative NMR studies enables HOS characterization and showcases the sensitivity and specificity in detecting differences in the spectra of mAbs after pH-thermal forced degradation with respect to local and global protein structure.

Indexed as

Antibodies, MonoclonalChemometricsAdalimumabHydrogen-Ion ConcentrationMagnetic Resonance SpectroscopyTrastuzumabAdalimumabAntibodies, MonoclonalTrastuzumabantibodiesbiopharmaceutical characterizationchemometricsnuclear magnetic resonance (NMR) spectroscopyprotein structure

Identifiers

PMID37798537
PMCPMC10661726
OpenAlexW4387360467

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.