Evidence map›Paper›PMID 41826586›Full record

ArticlePharmaceutical research2026

The Effect of Pharmaceutical Excipients on Protein Chemical Degradation Through Deamidation and Isomerization.

Ingrid Ramm, Carl Diehl, Amanda Västberg, Johanna Hjalte, Herje Schagerlöf, Marie Wahlgren, Lars Nilsson

Abstract read
In one paragraph

Article in Pharmaceutical research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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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

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Ingrid RammDepartment of Process and Life Science Engineering, Lund University, 221 00, Lund, Sweden.
Carl DiehlSARomics Biostructures AB, 223 63, Lund, Sweden.
Amanda VästbergDepartment of Process and Life Science Engineering, Lund University, 221 00, Lund, Sweden.
Johanna HjalteDepartment of Process and Life Science Engineering, Lund University, 221 00, Lund, Sweden.
Herje SchagerlöfDepartment of Process and Life Science Engineering, Lund University, 221 00, Lund, Sweden.
Marie WahlgrenDepartment of Process and Life Science Engineering, Lund University, 221 00, Lund, Sweden.
Lars NilssonDepartment of Process and Life Science Engineering, Lund University, 221 00, Lund, Sweden. lars.nilsson@ple.lth.se.ORCID http://orcid.org/0000-0002-6769-2641

Funding

VINNOVA 2018-04730
6 · The paper itself

Abstract

introductionTherapeutic proteins are crucial in the treatment of a wide range of diseases. However, the proteins are sensitive to chemical degradation reactions, particularly deamidation and isomerization, which can compromise efficacy and safety. Formulation excipients, such as sugars and non-ionic surfactants, are commonly used to enhance stability, yet their effects on chemical degradation remain insufficiently understood.

methodsThis study investigates how fructose, sucrose, melezitose, and the non-ionic surfactants polysorbate 80 and DDM (n-Dodecyl-β-D-maltoside) affect the structure and chemical stability of the affibody GA-Z, a protein prone to deamidation and isomerization. Chemical degradation and conformational changes were characterized using peptide fingerprinting, Liquid Chromatography-Mass Spectrometry, Titration fluorescence spectroscopy, two-dimensional Nuclear Magnetic Resonance spectroscopy, and Differential Scanning Calorimetry.

resultsAll three sugars lowered chemical degradation by stabilizing the folded state of the z-domain and inducing minor structural changes in the albumin-binding domain, thereby lowering the propensity for deamidation and isomerization. Polysorbate 80 showed minimal impact on both degradation and protein structure. In contrast, DDM increased deamidation and isomerization due to surfactant-protein interactions, resulting in structural changes.

conclusionThese results demonstrate how excipient-induced structural changes affect chemical degradation of proteins in liquid formulations. This study contributes to the understanding and design of more effective formulations for therapeutic proteins, enhancing their stability and safety.

Indexed as

ExcipientsAmidesIsomerismPolysorbatesProtein StabilitySurface-Active AgentsAmidesExcipientsPolysorbatesSurface-Active Agentschemical stabilitydeamidationliquid formulationstabilizing excipientstherapeutic proteins

Identifiers

PMID41826586
PMCPMC13179256

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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.