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Early And Preclinical Phase Solutions

Cerba Research offers comprehensive tissue analysis solutions from early discovery development projects to fully validated assays for phase III clinical trials. We have extensive experience with early and preclinical phase research on both small and large in vivo models for the development of new therapies of implantable medical devices.

Tissue Cross Reactivity (TCR) Studies

A gloved hand holding three glass slides with stained tissue samples on them

Tissue cross-reactivity (TCR) studies are used to evaluate the binding of antibody and antibody-like molecules on panels of tissues, most often by Immunohistochemistry (IHC). Detection of off-target binding does often not translate to notable toxicity, but alerts on which organs should be monitored closely for adverse effects. TCR studies can also result in the identification of new sites of on-target binding.


In order to avoid antigenic modifications that result from formalin fixation in the FFPE format, TCR studies are performed on frozen tissues. Animal tissue collections can be used to validate the choice of non-clinical species for toxicity testing. A regulatory panel of human samples from over 30 organs or structures are used in GLP-grade TCR studies for IND/CTA filing.

Cerba Research holds both animal and regulatory human tissue panels for quick starting of projects.

We can support your need for TCR testing from preliminary studies, where the antibody concentrations to be used are determined, to the full GLP TCR for regulatory submission.

Researcher using a machine to analyze a sample

Histopathology And IHC For In Vivo Models

Cerba Research has been offering tissue analysis for early and preclinical phase studies to the pharmaceutical and medical device industries for years. Several histology stains and IHC protocols are available, as well as analysis by veterinarian pathologists.

Our histology laboratory is Good Laboratory Practice-certified and GLP-compliant studies can be conducted.

Contact us for your early and preclinical phase project needs!

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