Evidence map›Paper›PMID 42479388›Full record

ArticleApplied biochemistry and biotechnology2026

Investigation of Payloads and Related Impurities in the cysteine-linked Antibody-Drug Conjugate Using Mass Spectrometry Techniques.

Gang Wu, Gangling Xu, Yue Zhao, Tie Gao, Yongbo Ni, Xiaolei Lv, Hongxu Chen, Meng Li, Jialiang Du, Chuanfei Yu

Abstract read
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In one paragraph

Article in Applied biochemistry and biotechnology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Gang Wu *National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, No. 31 Huatuo Road, Daxing District, Beijing, 102629, China.
Gangling Xu *National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, No. 31 Huatuo Road, Daxing District, Beijing, 102629, China.
Yue Zhao *Beijing Institute for Drug Control (Beijing Center for Vaccine Control), NMPA Center for Innovation and Research in Regulatory Science, No. 25 Keyuan Road, Changping District, Beijing, 102206, China.
Tie GaoSCIEX China, No.18 Science Park Road, Changping District, Beijing, 102206, P. R. China.
Yongbo NiNational Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, No. 31 Huatuo Road, Daxing District, Beijing, 102629, China.
Xiaolei LvSCIEX China, No.18 Science Park Road, Changping District, Beijing, 102206, P. R. China.
Hongxu ChenSCIEX China, No.18 Science Park Road, Changping District, Beijing, 102206, P. R. China.
Meng LiNational Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, No. 31 Huatuo Road, Daxing District, Beijing, 102629, China.
Jialiang DuNational Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, No. 31 Huatuo Road, Daxing District, Beijing, 102629, China.
Chuanfei YuNational Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, No. 31 Huatuo Road, Daxing District, Beijing, 102629, China. yucf@nifdc.org.cn.

Funding

Beijing Municipal Science and Technology Commission Z251100004625003National Key Research and Development Program of China 2023YFC3404004Standardization Improvement Project of Chinese Pharmacopeiae BZ2025137State Key Laboratory of Drug Regulatory science 2025SKLDRS0336
6 · The paper itself

Abstract

Loncastuximab tesirine is a cysteine-linked antibody-drug conjugate composed of an anti-CD19 monoclonal antibody linked to the PBD dimer payload SG3249 via a protease-cleavable linker, enabling targeted release of a highly cytotoxic DNA cross-linking agent. NAC-SG3249, a thiol adduct formed with N-acetylcysteine, serves as an important indicator of payload release and ADC stability. In this study, mass spectrometry techniques were employed to systematically investigate the stability and related small-molecule impurities of this ADC. Quantitative analysis of the free payload showed good linearity over 0.05-100 ng/mL (R² ≥ 0.991), with an LLOQ of 0.05 ng/mL, accuracy of 80%-120%, and precision below 5%, and the results were consistent between HRMS and TQMS, both methods can achieve effective quantification. Potential payload-related impurities were further characterized based on predicted hydrolysis pathways using targeted MRM analysis. Forced degradation studies under acidic, alkaline, photolytic, and thermal conditions revealed multiple degradation products using a highly sensitive nanoLC-HRMS method, with alkaline conditions producing the greatest number of impurities. Clinical trial number: not applicable.

Indexed as

Antibody–drug conjugateHigh-resolution mass spectrometryQuantitationSmall molecular related impuritiesStability study

Identifiers

PMID42479388

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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.