Evidence map›Paper›PMID 28758834›Full record

ArticlemAbs2017

Preferential interactions of trehalose, L-arginine.HCl and sodium chloride with therapeutically relevant IgG1 monoclonal antibodies.

Chaitanya Sudrik, Theresa Cloutier, Phuong Pham, Hardeep S Samra, Bernhardt L Trout

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in mAbs, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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

16 citing papers in PubMed.

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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.

Chaitanya Sudrika Department of Chemical Engineering, Massachusetts Institute of Technology , Cambridge , MA , USA.
Theresa Cloutiera Department of Chemical Engineering, Massachusetts Institute of Technology , Cambridge , MA , USA.
Phuong Phama Department of Chemical Engineering, Massachusetts Institute of Technology , Cambridge , MA , USA.
Hardeep S Samrab Formulation Sciences, MedImmune LLC , Gaithersburg , MD , USA.
Bernhardt L Trouta Department of Chemical Engineering, Massachusetts Institute of Technology , Cambridge , MA , USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Preferential interactions of weakly interacting formulation excipients govern their effect on the equilibrium and kinetics of several reactions of protein molecules in solution. Using vapor pressure osmometry, we characterized the preferential interactions of commonly used excipients trehalose, L-arginine.HCl and NaCl with three therapeutically-relevant, IgG1 monoclonal antibodies that have similar size and shape, but differ in their surface hydrophobicity and net charge. We further characterized the effect of these excipients on the reversible self-association, aggregation and viscosity behavior of these antibody molecules. We report that trehalose, L-arginine.HCl and NaCl are all excluded from the surface of the three IgG1 monoclonal antibodies, and that the exclusion behavior is linearly related to the excipient molality in the case of trehalose and NaCl, whereas a non-linear behavior is observed for L-arginine.HCl. Interestingly, we find that the magnitude of trehalose exclusion depends upon the nature of the protein surface. Such behavior is not observed in case of NaCl and L-arginine.HCl as they are excluded to the same extent from the surface of all three antibody molecules tested in this study. Analysis of data presented in this study provides further insight into the mechanisms governing excipient-mediated stabilization of mAb formulations.

Indexed as

Antibodies, MonoclonalArginineDrug StabilityExcipientsImmunoglobulin GOsmometrySodium ChlorideTrehaloseAntibodies, MonoclonalArginineExcipientsImmunoglobulin GSodium ChlorideTrehaloseL-arginine.HClmAb stabilitypreferential exclusionpreferential hydrationsodium chloridetherapeutic monoclonal antibody formulationTrehalosevapor pressure osmometry

Identifiers

PMID28758834
PMCPMC5627590

What OpenQuestion holds

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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.