Development of production methodologies for scFv-Fc conjugated critical reagents to support CAR-T clinical programs
As a result of these studies herein, optimal stable conjugated critical reagents were produced which enabled successful development and validation of clinical CAR-T ADA assay. This work provides a framework that can be applied to the production of other bioanalytical assay critical reagents when platform conjugation approaches fail.
Authors
- Dewald van Dyk
- Ellen O’Connor
- A. Salvador Salas (ORCID: https://orcid.org/0000-0001-5041-5659)
- Neil Mody (ORCID: https://orcid.org/0000-0003-2260-7658)
- Mitali Shah
- Jared A. Delmar
- Chris Griffin (ORCID: https://orcid.org/0009-0009-3937-6834)
- Yueming Xu (ORCID: https://orcid.org/0000-0002-9300-9703)
- R. P. Lin (ORCID: https://orcid.org/0009-0000-1468-6734)
- Samuel Frederick Edwards
- Natalia Schoch-Lopez
- Bradley D’souza
- Ai Shih
- Eric Lachacz
Institutions
- AstraZeneca (Netherlands) (NL)
- AstraZeneca (Brazil) (BR)
- AstraZeneca (Japan) (JP)
- AstraZeneca (Poland) (PL)
- AstraZeneca (Spain) (ES)
Publication Details
- Journal
- Bioanalysis
- Published
- 2025-11-14
- DOI
- https://doi.org/10.1080/17576180.2025.2587001
- Primary Topic
- CAR-T cell therapy research
- Type
- article
- Field-Weighted Citation Impact
- 0.00