CROs for Antibody Programs: In Vivo Pharmacology and Safety

2 contract research organizations in our directory list Antibody Programs as a capability, across 2 countries. 0 report GLP capability and 0 report AAALAC accreditation. Compare their species, services and accreditations below, and contact labs directly from their profiles.

2 CROs 2 countries

About Antibody Programs

Antibody programs succeed or stall on one question asked early: does the antibody bind the target in the animal you plan to use? Many therapeutic antibodies are selected against the human protein and do not cross-react with the mouse or rat version, which rules out standard rodent efficacy models. CROs that run in vivo pharmacology for antibody programs usually offer one or more ways around this: humanized target knock-in mice, a surrogate antibody against the rodent target, human tumor xenografts where the target is on the human cells, or a nonhuman primate study when only primates share the epitope.

Pharmacokinetics behaves differently from small molecules. Antibody half-life depends on FcRn recycling, so human FcRn transgenic mice are often used to predict human PK, and target-mediated drug disposition can make clearance dose-dependent. In repeat-dose rodent studies, anti-drug antibodies against a human protein can clear the drug and erase exposure, so plan immunogenicity sampling and a validated ADA assay alongside the ligand binding PK assay.

For safety, ICH S6(R1) asks for testing in a pharmacologically relevant species, which for many antibodies means the cynomolgus monkey alone. A tissue cross-reactivity study on human and animal tissue panels supports species selection. Bispecific T-cell engagers and other immune agonists add cytokine release risk, so in vitro cytokine release assays with human cells and a MABEL-based starting dose often come into play.

Species selection guide →

Showing 2 CROs. Order rotates daily so no lab is permanently listed first.

genOway

FR

Lyon-based company creating genetically engineered and humanized rodent models, with catalog models and in vivo research services.

Antibody Programs In Vivo Efficacy Oncology Models Mouse Rat

Biocytogen

CN

Beijing-based company providing genetically engineered and humanized mouse models with in vivo pharmacology services, especially for oncology and immunology antibody programs.

Antibody Programs In Vivo Efficacy Oncology Models Syngeneic Models Xenograft Models Mouse

Questions to ask when choosing an Antibody Programs CRO

  • Has cross-reactivity of our antibody been confirmed in the species and strain you propose for efficacy and toxicology?
  • Do you offer humanized target or human FcRn transgenic mice, and can you run studies with a surrogate antibody?
  • Which ligand binding platform will measure PK, and do you also run ADA and neutralizing antibody assays?
  • How do you account for anti-drug antibodies when interpreting exposure in repeat-dose rodent studies?
  • Can you run a tissue cross-reactivity study, or do you work with a partner pathology lab for it?
  • For bispecifics or immune agonists, do you run in vitro cytokine release assays with human cells?