Evidence map›Paper›PMID 35090111›Full record

ArticleJournal of medicinal chemistry2022

Aggregation Time Machine: A Platform for the Prediction and Optimization of Long-Term Antibody Stability Using Short-Term Kinetic Analysis.

Marko Bunc, San Hadži, Christian Graf, Matjaž Bončina, Jurij Lah

Abstract read
In one paragraph

Article in Journal of medicinal chemistry, 2022. 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
–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

12 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.

Marko BuncTechnical Research and Development, Global Drug Development, Novartis, Lek d.d., 1234 Mengeš, Slovenia.ORCID 0000-0001-8763-2243
San HadžiFaculty of Chemistry and Chemical Technology, University of Ljubljana, 1000 Ljubljana, Slovenia.ORCID 0000-0002-5615-7918
Christian GrafTechnical Research and Development, Global Drug Development, Novartis, Hexal AG, 82041 Oberhaching, Germany.
Matjaž BončinaTechnical Research and Development, Global Drug Development, Novartis, Lek d.d., 1234 Mengeš, Slovenia.
Jurij LahFaculty of Chemistry and Chemical Technology, University of Ljubljana, 1000 Ljubljana, Slovenia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Monoclonal antibodies are the fastest growing class of therapeutics. However, aggregation limits their shelf life and can lead to adverse immune responses. Assessment and optimization of the long-term antibody stability are therefore key challenges in the biologic drug development. Here, we present a platform based on the analysis of temperature-dependent aggregation data that can dramatically shorten the assessment of the long-term aggregation stability and thus accelerate the optimization of antibody formulations. For a set of antibodies used in the therapeutic areas from oncology to rheumatology and osteoporosis, we obtain an accurate prediction of aggregate fractions for up to three years using the data obtained on a much shorter time scale. Significantly, the strategy combining kinetic and thermodynamic analysis not only contributes to a better understanding of the molecular mechanisms of antibody aggregation but has already proven to be very effective in the development and production of biological therapeutics.

Indexed as

Protein AggregatesAntibodies, MonoclonalHumansKineticsProtein MultimerizationProtein StabilityTemperatureAntibodies, MonoclonalProtein Aggregates

Identifiers

PMID35090111
PMCPMC8842250

What OpenQuestion holds

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LicenceCC BY
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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.