Evidence map›Paper›PMID 39663541›Full record

ArticlemAbs

Reconciling predicted and measured viscosity parameters in high concentration therapeutic antibody solutions.

Georgina Bethany Armstrong, Aisling Roche, William Lewis, Zahra Rattray

Abstract 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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

4 authors.

Georgina Bethany ArmstrongDrug Substance Development, GlaxoSmithKline, Stevenage, UK.
Aisling RocheLarge Molecule Discovery, GlaxoSmithKline, Stevenage, UK.
William LewisDrug Substance Development, GlaxoSmithKline, Stevenage, UK.
Zahra RattrayStrathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK.ORCID 0000-0002-8371-8549

Funding

UK Biotechnology and Biological Sciences Research Council BB/Y003268/1UK Engineering and Physical Sciences Research Council EP/V028960/1
6 · The paper itself

Abstract

Monoclonal antibody (mAb) solution viscosity in ultra-high concentration formulations is a key developability consideration in mAb development risk mitigation strategies that has implications for downstream processing and patient safety. Predicting viscosity at therapeutically relevant concentrations remains critical, despite the need for large mAb quantities for viscosity measurement being prohibitive. Using a panel of IgG1s, we examined the suitability of viscosity prediction and fitting models at different mAb test concentration regimes. Our findings caution against extrapolation from low concentration measurements, as they lack predictive ability for ultra-high concentration regimes. For the first time, we demonstrate the importance of analyte concentration range selection, and the need for bespoke viscosity model development.

Indexed as

Antibodies, MonoclonalHumansImmunoglobulin GSolutionsViscosityAntibodies, MonoclonalImmunoglobulin GSolutionsAntibodyformulationphysicochemical descriptorspredictionviscosity

Identifiers

PMID39663541
PMCPMC11790245

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.