Evidence map›Paper›PMID 33037499›Full record

ReviewThe AAPS journal2020

Bioanalytical Challenges in Support of Complex Modalities of Antibody-Based Therapeutics.

Liang Zhu, Jim Glick, Jimmy Flarakos

Abstract readReview
PubMed Publisher
In one paragraph

Review in The AAPS journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
  2. Review
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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

3 authors.

Liang ZhuPK Sciences, Novartis Institute for Biomedical Research, 250 Massachusetts Avenue, Cambridge, Massachusetts, 02139, USA. liang.zhu@novartis.com.ORCID 0000-0002-6948-2103
Jim GlickPK Sciences, Novartis Institute for Biomedical Research, 250 Massachusetts Avenue, Cambridge, Massachusetts, 02139, USA.
Jimmy FlarakosPK Sciences, Novartis Institute for Biomedical Research, 250 Massachusetts Avenue, Cambridge, Massachusetts, 02139, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Antibody-based therapeutic classes are evolving from monoclonal antibodies to antibody derivatives with complex structures to achieve advanced therapeutic effect. These antibody derivatives may contain multiple functional domains and are often vulnerable to in vivo biotransformation. Understanding the pharmacokinetics of these antibody derivatives requires a sophisticated bioanalytical approach to carefully characterize the whole drug and each functional domain with respect to quantity, functionality enabled by biotransformation, and corresponding immune responses. Ligand binding assays and liquid chromatography-mass spectrometry assays are predominantly used in bioanalytical support of monoclonal antibodies and are continuously used for antibody derivatives such as antibody drug conjugate and bispecific antibodies. However, they become increasingly cumbersome in coping with increased complexity of drug modality and associated biotransformation. In this mini-review, we examined the current pharmacokinetic assays in the literature for antibody drug conjugate and bispecific antibodies, and presented our view of promising bioanalytical technologies to address the distinct bioanalytical needs of complex modalities.

Indexed as

Antibodies, BispecificBiological AssayBiotransformationChromatography, High Pressure LiquidDrug DevelopmentHumansImmunoconjugatesTandem Mass SpectrometryAntibodies, BispecificImmunoconjugatesantibody drug conjugatebioanalyticalbispecific antibodyligand binding assayliquid chromatograph-mass spectrometry

Identifiers

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.