Evidence map›Paper›PMID 32249670›Full record

ArticlemAbs

Predicting Antibody Developability Profiles Through Early Stage Discovery Screening.

Marc Bailly, Carl Mieczkowski, Veronica Juan, Essam Metwally, Daniela Tomazela, Jeanne Baker, Makiko Uchida, Ester Kofman, Fahimeh Raoufi, Soha Motlagh and 12 more

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 135 papers.

0numbers the graph read from it
0cells of the map it votes in
135citing 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

135 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Review

75 more citing papers are in PubMed but not listed here.

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

22 authors.

Marc BaillyDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Carl MieczkowskiDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Veronica JuanDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Essam MetwallyComputation and Structural Chemistry, South San Francisco, CA, USA.
Daniela TomazelaDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Jeanne BakerDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Makiko UchidaDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Ester KofmanDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Fahimeh RaoufiDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Soha MotlaghDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Yao YuDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Jihea ParkDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Smita RaghavaPharmaceutical Sciences, Sterile FormulationSciences, Kenilworth, NJ, USA.
John WelshDownstream Process Development andEngineering, Kenilworth, NJ, USA.
Michael RauscherDownstream Process Development andEngineering, Kenilworth, NJ, USA.
Gopalan RaghunathanDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Mark HsiehDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Yi-Ling ChenDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Hang Thu NguyenDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Nhung NguyenDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Dan CiprianoDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.
Laurence Fayadat-DilmanDiscovery Biologics, Protein Sciences, South San Francisco, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Monoclonal antibodies play an increasingly important role for the development of new drugs across multiple therapy areas. The term 'developability' encompasses the feasibility of molecules to successfully progress from discovery to development via evaluation of their physicochemical properties. These properties include the tendency for self-interaction and aggregation, thermal stability, colloidal stability, and optimization of their properties through sequence engineering. Selection of the best antibody molecule based on biological function, efficacy, safety, and developability allows for a streamlined and successful CMC phase. An efficient and practical high-throughput developability workflow (100 s-1,000 s of molecules) implemented during early antibody generation and screening is crucial to select the best lead candidates. This involves careful assessment of critical developability parameters, combined with binding affinity and biological properties evaluation using small amounts of purified material (<1 mg), as well as an efficient data management and database system. Herein, a panel of 152 various human or humanized monoclonal antibodies was analyzed in biophysical property assays. Correlations between assays for different sets of properties were established. We demonstrated in two case studies that physicochemical properties and key assay endpoints correlate with key downstream process parameters. The workflow allows the elimination of antibodies with suboptimal properties and a rank ordering of molecules for further evaluation early in the candidate selection process. This enables any further engineering for problematic sequence attributes without affecting program timelines.

Indexed as

Antibodies, MonoclonalWorkflowDrug DiscoveryHumansProtein EngineeringAntibodies, Monoclonalantibody discoveryantibody screeningbiophysical propertiesCMCdevelopabilitymanufacturabilityMonoclonal antibodiesprotein analyticsprotein engineering

Identifiers

PMID32249670
PMCPMC7153844

What OpenQuestion holds

Textmetadata
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.