Evidence map›Paper›PMID 39036070›Full record

ArticleAntibody therapeutics2024

A case study of a bispecific antibody manufacturability assessment and optimization during discovery stage and its implications.

Shuang Wang, Weijie Zhang, Baotian Yang, Xudong Zhang, Jing Fang, Haopeng Rui, Zhijian Chen, Jijie Gu, Zhiqiang Chen, Jianqing Xu

Erratum issuedAbstract read
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Article in Antibody therapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Shuang WangBiologics Innovation Discovery, WuXi Biologics, 1951 Huifeng West Road, Fengxian District, Shanghai, 201400, China.ORCID https://orcid.org/0000-0003-4321-9881
Weijie ZhangBiologics Innovation Discovery, WuXi Biologics, 1951 Huifeng West Road, Fengxian District, Shanghai, 201400, China.
Baotian YangBiologics Innovation Discovery, WuXi Biologics, 1951 Huifeng West Road, Fengxian District, Shanghai, 201400, China.
Xudong ZhangDownstream Process Development (DSPD), WuXi Biologics, 288 Fute Zhong Road, Waigaoqiao Free Trade Zone, Shanghai, 200131, China.
Jing FangBiologics Innovation Discovery, WuXi Biologics, 1951 Huifeng West Road, Fengxian District, Shanghai, 201400, China.
Haopeng RuiD3 Bio (Wuxi) Co., Ltd., 1101, 11/F, Building 1, No.6, Lane 38, Yuanshen Road, Pudong, Shanghai, 200120, China.
Zhijian ChenD3 Bio (Wuxi) Co., Ltd., 1101, 11/F, Building 1, No.6, Lane 38, Yuanshen Road, Pudong, Shanghai, 200120, China.
Jijie GuBiologics Innovation Discovery, WuXi Biologics, 1951 Huifeng West Road, Fengxian District, Shanghai, 201400, China.
Zhiqiang ChenD3 Bio (Wuxi) Co., Ltd., 1101, 11/F, Building 1, No.6, Lane 38, Yuanshen Road, Pudong, Shanghai, 200120, China.
Jianqing XuBiologics Innovation Discovery, WuXi Biologics, 1951 Huifeng West Road, Fengxian District, Shanghai, 201400, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The manufacturability assessment and optimization of bispecific antibodies (bsAbs) during the discovery stage are crucial for the success of the drug development process, impacting the speed and cost of advancing such therapeutics to the Investigational New Drug (IND) stage and ultimately to the market. The complexity of bsAbs creates challenges in employing effective evaluation methods to detect developability risks in early discovery stage, and poses difficulties in identifying the root causes and implementing subsequent engineering solutions. This study presents a case of engineering a bsAb that displayed a normal solution appearance during the discovery phase but underwent significant precipitation when subjected to agitation stress during 15 L Chemistry, Manufacturing, and Control (CMC) production Leveraging analytical tools, structural analysis,

Indexed as

agitation-induced aggregationbsAbdevelopabilitymanufacturabilityprotein engineering

Identifiers

PMID39036070
PMCPMC11259756

What OpenQuestion holds

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Registered trials

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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.