Evidence map›Paper›PMID 30543482›Full record

ReviewmAbs

Structure, heterogeneity and developability assessment of therapeutic antibodies.

Yingda Xu, Dongdong Wang, Bruce Mason, Tony Rossomando, Ning Li, Dingjiang Liu, Jason K Cheung, Wei Xu, Smita Raghava, Amit Katiyar and 6 more

Open access · goldAbstract readReview
In one paragraph

Review in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 126 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
126citing papers in PubMed, 1 pooled it
17.2field-weighted citation impact, top 1% of its field
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

126 citing papers in PubMed, 1 synthesis or guideline pooled it, 257 citations in OpenAlex.

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66 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

16 authors at 7 institutions in 2 countries.

Yingda Xua Protein Analytics , Adimab , Lebanon , NH , USA.
Dongdong Wangb Analytical Department , Bioanalytix, Inc ., Cambridge , MA , USA.
Bruce Masonc Product Characterization , Alexion Pharmaceuticals, Inc ., New Haven , CT , USA.
Tony Rossomandoc Product Characterization , Alexion Pharmaceuticals, Inc ., New Haven , CT , USA.
Ning Lid Analytical Chemistry , Regeneron Pharmaceuticals, Inc ., Tarrytown , NY , USA.
Dingjiang Liue Formulation Development , Regeneron Pharmaceuticals, Inc ., Tarrytown , NY , USA.ORCID 0000-0002-8665-2426
Jason K Cheungf Pharmaceutical Sciences , MRL, Merck & Co., Inc ., Kenilworth , NJ , USA.
Wei Xug Analytical Method Development , MRL, Merck & Co., Inc ., Kenilworth , NJ , USA.
Smita Raghavah Sterile Formulation Sciences , MRL, Merck & Co., Inc ., Kenilworth , NJ , USA.
Amit Katiyari Analytical Development , Bristol-Myers Squibb , Pennington , NJ , USA.
Christine Nowakc Product Characterization , Alexion Pharmaceuticals, Inc ., New Haven , CT , USA.
Tao Xiangj Manufacturing Sciences , Abbvie Bioresearch Center , Worcester , MA , USA.
Diane D Dongj Manufacturing Sciences , Abbvie Bioresearch Center , Worcester , MA , USA.
Joanne Sunk Product development , Innovent Biologics , Suzhou Industrial Park , China.
Alain Beckl Analytical chemistry , NBEs, Center d'immunologie Pierre Fabre , St Julien-en-Genevois Cedex , France.
Hongcheng Liuc Product Characterization , Alexion Pharmaceuticals, Inc ., New Haven , CT , USA.
Alexion Pharmaceuticals (United States) · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USAbbVie (United States) · USRegeneron (United States) · USAdimab (United States) · USBristol-Myers Squibb (United States) · USCenter of Immunology Pierre Fabre · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Increasing attention has been paid to developability assessment with the understanding that thorough evaluation of monoclonal antibody lead candidates at an early stage can avoid delays during late-stage development. The concept of developability is based on the knowledge gained from the successful development of approximately 80 marketed antibody and Fc-fusion protein drug products and from the lessons learned from many failed development programs over the last three decades. Here, we reviewed antibody quality attributes that are critical to development and traditional and state-of-the-art analytical methods to monitor those attributes. Based on our collective experiences, a practical workflow is proposed as a best practice for developability assessment including in silico evaluation, extended characterization and forced degradation using appropriate analytical methods that allow characterization with limited material consumption and fast turnaround time.

Indexed as

Antibodies, MonoclonalDrug DiscoveryHumansAntibodies, MonoclonalDevelopabilitymonoclonal antibodyposttranslational modifications

Identifiers

PMID30543482
PMCPMC6380400
OpenAlexW2904971004

What OpenQuestion holds

Textmetadata
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.