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Tissue Cross-Reactivity studies of antibodies

TCR studies at P.A.R.I.S: Step by step: a timely and cost effective approach

Are you working on an antibody drug candidate? Do you need to characterized it?

Tissue Cross-Reactivity studies give key data for the development of monoclonal antibodies. They assure that the experimental antibody binds to the target site and does not bind to epitopes other than the target what could lead to treatment-related toxicity in humans.

P.A.R.I.S offers Tissue Cross-Reactivity studies, both GLP and non-GLP in support of your research or your preclinical therapeutic antibody development.

The service

  • A dedicated team of pathologists and specialized histotechnicians
  • GLP qualified Ventana Discovery & Ventana Benchmark automats
  • All the human tissues are purchased from suppliers who strictly respect legal and ethical requirements
  • All the protocols are validated
  • P.A.R.I.S supplies a full and illustrated report for each phase, not only for the GLP study 

The approach

Phase 1 : Optimization and validation of the staining conditions

During this phase the protocol is optimized and validated. This is essential to ensure the reliability of cross-reactivity study results.

Phase 2 : Pilot study

Pilot tissue cross-reactivity studies allow you to quickly acquire data on the antibody.

These studies can be perfomed on normal or tumoral human tissues, animal tissues, frozen or FFPE tissues, on tissues from 1 or 3 donnors.

We advise you to perform a pilot cross-reactivity study on frozen human tissues from 1 or 3 donnors to identify the potential cross-reactivity of your antibody prior to a GLP-compliant study.

The pilot studies are also suitable for any data acquisition on the target for research purposes.

Phase 3 : GLP study

As part of the investigational new drug (IND) application procedure, this full cross-reactivity study is performed in accordance with the FDA's recommandations.

The study is perfomed on 32 frozen normal human tissues of 3 unrelated donnors.

The recommandations

For the antibodies, the regulatory agencies (FDA, EMEA, ICH) require tissue cross-reactivity studies to be performed prior to the clinical phases. The recommandations are defined inThe FDA points to consider document in the Manufacturing and Testing of Monoclonal Antibody Products For Human Use (FDA PTC 1997), The EMEA Guideline on development, production, characterisation and specifications for monoclonal antibodies and related products (2009) and homogeneized by the ICH in The ICH S6 Guidance for Industry on Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (1997).

The cross-reactivity data should be generated in compliance with Good Laboratory Practice (GLP).

To optimize your GLP studies, P.A.R.I.S offers to work step by step with go/no go decisions.

 

For further information, please contact us