Evidence map›Paper›PMID 33942188›Full record

ReviewThe AAPS journal2021

Bioanalysis in the Age of New Drug Modalities.

Jing Shi, Xuesong Chen, Jianbo Diao, Liying Jiang, Lan Li, Stephen Li, Wenzhong Liang, Xiaoying Jin, Yonghui Wang, Colton Wong and 2 more

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in The AAPS journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
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

12 authors.

Jing ShiBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China. shi_jing@wuxiapptec.com.ORCID 0000-0003-2366-1824
Xuesong ChenBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.
Jianbo DiaoBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.
Liying JiangBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.
Lan LiBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.
Stephen LiBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.
Wenzhong LiangBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.
Xiaoying JinBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.
Yonghui WangBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.
Colton WongBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.
Xiaolong Tom ZhangBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.
Francis L S TseBioanalytical Services Department, WuXi AppTec, 288 Fute Zhong Road, Waigaoqiao, Shanghai, 200131, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the absence of regulatory guidelines for the bioanalysis of new drug modalities, many of which contain multiple functional domains, bioanalytical strategies have been carefully designed to characterize the intact drug and each functional domain in terms of quantity, functionality, biotransformation, and immunogenicity. The present review focuses on the bioanalytical challenges and considerations for RNA-based drugs, bispecific antibodies and multi-domain protein therapeutics, prodrugs, gene and cell therapies, and fusion proteins. Methods ranging from the conventional ligand binding assays and liquid chromatography-mass spectrometry assays to quantitative polymerase chain reaction or flow cytometry often used for oligonucleotides and cell and gene therapies are discussed. Best practices for method selection and validation are proposed as well as a future perspective to address the bioanalytical needs of complex modalities.

Indexed as

Guidelines as TopicAntibodies, BispecificBiological AssayCell- and Tissue-Based TherapyChromatography, LiquidDrug DevelopmentFlow CytometryGenetic TherapyMass SpectrometryOligonucleotidesProdrugsRecombinant Fusion ProteinsRNAAntibodies, BispecificOligonucleotidesProdrugsRecombinant Fusion ProteinsRNAbioanalysiscell and gene therapyimmunogenicityNew drug modalityoligonuleotide

Identifiers

PMID33942188
PMCPMC8093172

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.