Therapeutic Antibody Evaluation Services

The JAX Therapeutic Antibody Evaluation Services rely on a unique humanized mouse collection. Using our humanized FcRn models we deliver accurate data to get your therapeutic candidate into the clinic—and ultimately in the hands of physician and patients—faster.

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From preclinical to clinical: get relevant translational and fast half-life comparison data

We evaluate the in vivo stability of therapeutic antibodies and other Fc-based biologics using our unique platform consisting of humanized mouse models that are deficient in murine FcRn and express human FcRn at different levels. Developed by JAX professor Derry Roopenian, Ph.D., these mice allow for

generation of faster, predicative clinically-relevant data for antibody stability,
an effective and proven alternative to non-human primates,
preclinical pharmacokinetic (PK) analysis of Fc-domain based therapeutic candidates,
cost effectiveness, since they require only small quantities of a given molecule,
testing of any kind of Fc-domain albumin-conjugate, or therapeutic carried by albumin used in immuno-oncology and autoimmune research, among others

Clinical Relevancy of Preclinical Models for Pharmacokinetics

Model	Cost	Correlation with Human Data
In Vitro	Low	Low
Standard mice	Moderate	Low
Humanized FcRn mice	Moderate	Very good
Non-human primates	High	Very good

The Humanized Mouse Platform: Description of the Most Used Models

B6.Cg-Fcgrt^tm1Dcr Tg(FCGRT)32Dcr/DcrJ (014565) mice have a null mutation for the mouse gene and a transgene expressing the human FcRn under the endogenous promoter (hTg32). These mice have the highest, most human-like protection of humanized IgG and are the best model for use when maximum half-life data is required.

B6.Cg-Fcgrt^tm1Dcr Tg(CAG-FCGRT)276Dcr/DcrJ (004919) mice carry a null mutation for the mouse gene and a transgene expressing human FcRn. Mice hemizygous for the human FcRn transgene (hTg276) are best suited to detect subtle differences in antibody persistence in vivo.

B6.Cg-Fcgrt^tm1DcrPrkdc^scidTg(FCGRT)32Dcr/DcrJ (018441) mice express the hTg32 transgene and are immunodeficient. These mice have the highest, most human-like protection of humanized IgG and are useful in evaluating Fc-domain based therapeutics that are potentially immunogenic or involve xenografts.

B6.Cg-Alb^em12Mvw Fcgrt^tm1Dcr Tg(FCGRT)32Dcr/MvwJ (025201) albumin knockout hTg32 mice are an effective, human-like model for characterization of the pharmacokinetics of albumin-conjugates, or therapeutics carried by albumin.