Evidence map›Paper›PMID 29293399›Full record

ReviewmAbs

Challenges and new frontiers in analytical characterization of antibody-drug conjugates.

Anil Wagh, Hangtian Song, Ming Zeng, Li Tao, Tapan K Das

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 50 papers.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed
9.2field-weighted citation impact, top 2% 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

50 citing papers in PubMed, 112 citations in OpenAlex.

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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 at 1 institution in 1 country.

Anil Wagha Molecular & Analytical Development , Bristol-Myers Squibb , New Jersey , USA.
Hangtian Songa Molecular & Analytical Development , Bristol-Myers Squibb , New Jersey , USA.
Ming Zenga Molecular & Analytical Development , Bristol-Myers Squibb , New Jersey , USA.
Li Taoa Molecular & Analytical Development , Bristol-Myers Squibb , New Jersey , USA.
Tapan K Dasa Molecular & Analytical Development , Bristol-Myers Squibb , New Jersey , USA.ORCID 0000-0002-3641-3988
Bristol-Myers Squibb (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antibody-drug conjugates (ADCs) are a growing class of biotherapeutics in which a potent small molecule is linked to an antibody. ADCs are highly complex and structurally heterogeneous, typically containing numerous product-related species. One of the most impactful steps in ADC development is the identification of critical quality attributes to determine product characteristics that may affect safety and efficacy. However, due to the additional complexity of ADCs relative to the parent antibodies, establishing a solid understanding of the major quality attributes and determining their criticality are a major undertaking in ADC development. Here, we review the development challenges, especially for reliable detection of quality attributes, citing literature and new data from our laboratories, highlight recent improvements in major analytical techniques for ADC characterization and control, and discuss newer techniques, such as two-dimensional liquid chromatography, that have potential to be included in analytical control strategies.

Indexed as

HumansImmunoconjugatesImmunoconjugatesanalyticalAntibody-drug conjugatescharacterizationCQA, DARquality attributestability

Identifiers

PMID29293399
PMCPMC5825200
OpenAlexW2782267088

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.