Evidence map›Paper›PMID 32658605›Full record

ArticlemAbs

Rational optimization of a monoclonal antibody improves the aggregation propensity and enhances the CMC properties along the entire pharmaceutical process chain.

Joschka Bauer, Sven Mathias, Sebastian Kube, Kerstin Otte, Patrick Garidel, Martin Gamer, Michaela Blech, Simon Fischer, Anne R Karow-Zwick

Abstract readVideo-Audio Media
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 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.

  1. Review
  2. Fluorescence-Based Protein Stability Monitoring-A Review.International journal of molecular sciences · 2024
    Review
  3. Article
  4. How can we discover developable antibody-based biotherapeutics?Frontiers in molecular biosciences · 2023
    Review
  5. Article
  6. Review
  7. Intrinsic physicochemical profile of marketed antibody-based biotherapeutics.Proceedings of the National Academy of Sciences of the United States of America · 2021
    Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. 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

9 authors.

Joschka BauerEarly Stage Pharmaceutical Development, Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach/Riss, Germany.
Sven MathiasInstitute of Applied Biotechnology, University of Applied Sciences Biberach , Biberach/Riss, Germany.
Sebastian KubeEarly Stage Pharmaceutical Development, Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach/Riss, Germany.
Kerstin OtteInstitute of Applied Biotechnology, University of Applied Sciences Biberach , Biberach/Riss, Germany.
Patrick GaridelEarly Stage Pharmaceutical Development, Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach/Riss, Germany.
Martin GamerEarly Stage Bioprocess Development, Bioprocess Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach/Riss, Germany.
Michaela BlechEarly Stage Pharmaceutical Development, Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach/Riss, Germany.
Simon FischerCell Line Development, Bioprocess Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach/Riss, Germany.
Anne R Karow-ZwickEarly Stage Pharmaceutical Development, Pharmaceutical Development Biologicals, Boehringer Ingelheim Pharma GmbH & Co. KG , Biberach/Riss, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The discovery of therapeutic monoclonal antibodies (mAbs) primarily focuses on their biological activity favoring the selection of highly potent drug candidates. These candidates, however, may have physical or chemical attributes that lead to unfavorable chemistry, manufacturing, and control (CMC) properties, such as low product titers, conformational and colloidal instabilities, or poor solubility, which can hamper or even prevent development and manufacturing. Hence, there is an urgent need to consider the developability of mAb candidates during lead identification and optimization. This work provides a comprehensive proof of concept study for the significantly improved developability of a mAb variant that was optimized with the help of sophisticated

Indexed as

Antibodies, MonoclonalProtein AggregatesAmino Acid SubstitutionAnimalsCHO CellsCricetulusHumansSolubilityAntibodies, MonoclonalProtein Aggregatesantibody engineeringbioinformaticbiotherapeutic developmentCMC propertiesIn silicopharmaceutical industry

Identifiers

PMID32658605
PMCPMC7531517

What OpenQuestion holds

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LicenceCC BY-NC
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.