ReviewAAPS PharmSciTech2026
Analytical Development and Testing Strategy of Antibody-Drug Conjugates.
Review in AAPS PharmSciTech, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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.
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.
Who cites it
1 citing paper in PubMed.
- Antibody-Drug Conjugates Drug Product Formulation and Process Development, Scalability and Stability Considerations.AAPS PharmSciTech · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Antibody-drug conjugates (ADCs) have gained significant successes in the cancer treatment and are expanding rapidly into other therapeutic areas. This review outlines the integration of the analytical development and process development based on the technical challenges and control strategy of different process stages from the antibody intermediate, drug-linker intermediate, ADC drug substance (DS) to drug product (DP). The priority of analytical method development should be tailored to support the cascades of process development decision-making at early-stage, while additional analytical development for process characterization and product understanding should be planned to deliver a comprehensive analytical control strategy at late-stage for licensure. The development strategy of a few unique ADC methods including drug-antibody ratio (DAR), residual free drug quantitation, and cytotoxicity assay (bioassay) are discussed. Furthermore, the QC testing network should be strategized to allow fast speed to IND and clinical trial; the approaches including consolidated QC testing, central QC lab, one-stop shop, and conditional release may be considered and adjusted from early to late-stage product development.
Indexed as
Identifiers
41851397What OpenQuestion holds
Registered trials
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.