About Bispecific Antibody Development
Bispecific antibodies bind two targets at once. The largest group, T-cell engagers, links a tumor or disease antigen to CD3 on T cells, so the molecule directs T cells to kill target cells. Preclinical work spans engineering and production of the format, in vitro potency and safety assays, in vivo efficacy and nonclinical safety.
The central potency assay for T-cell engagers is T-cell dependent cellular cytotoxicity (TDCC): target cells are co-cultured with human T cells or PBMC and the bispecific, and killing is measured across a dose range, usually alongside T-cell activation markers such as CD69 and CD25, proliferation and cytokine release. Because cytokine release syndrome is the main clinical risk, these in vitro data often support a minimal anticipated biological effect level (MABEL) approach to the first-in-human dose.
In vivo, efficacy is usually tested in humanized mice or immunodeficient mice reconstituted with human T cells. Safety studies need a species in which both arms bind, which is often only the cynomolgus monkey; when they do not, surrogate molecules may be needed.
Bispecific Antibody CROs: T-Cell Engagers and TDCC Assays
We don’t yet list a CRO offering Bispecific Antibody Development. Tell us about your study and we’ll help you source one.
Tell us about your studyQuestions to ask when choosing a Bispecific Antibody Development CRO
- Do you run TDCC assays with T cells or PBMC from multiple donors, and how do you handle donor variability?
- Which activation markers and cytokines do you measure alongside killing?
- Do you run cytokine release assays in whole blood or PBMC to support a MABEL-based starting dose?
- Which humanized or T-cell–reconstituted mouse models do you use for efficacy?
- Has cross-reactivity of both arms been confirmed in your proposed toxicology species?