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Tissue Cross-Reactivity Screening
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Asterand's Molecular Pathology team provides customers with a fully optimized immunohistochemical analysis of Human Tissue Cross-Reactivity and is a member of the UK GLP Compliance Monitoring Program.
A key factor in the success of these studies is the access to well characterized and annotated tissue. Asterand's extensive human tissue biorepository and supporting tissue supply network allows immediate access to high quality human tissues representing all tissue types required by both FDA (US) and EMEA (EU) for analysis of tissue cross-reactivity.
Our scientific expertise, experience in immunohistochemistry and access to high quality tissues enable us to efficiently deliver reliable tissue cross-reactivity data.
PhaseZERO® Solutions
For customers developing therapeutic antibodies as part of an IND program, the FDA, EMEA and ICH recommend the disclosure of data on cross-reactivity determined in human tissues. A further recommendation is that such safety data should be generated in compliance with Good Laboratory Practice (GLP).
Asterand's Tissue Cross-Reactivity Screening assays will provide confidence with a 'Go/No-Go' decision for antibodies of interest and minimize the opportunity of GLP and subsequent clinical study failure.
Typical Tissue Cross-Reactivity Screening Assay
Asterand's three Phase approach provides a competitive option of pre-GLP screening of antibody candidates using proprietary format frozen tissue microarrays (TMAs), prior to GLP-compliant analysis in full-face frozen tissue sections.
Phase 1: Tissue Cross-Reactivity assay optimization using positive / negative control tissues
Phase 1b: Non-GLP Tissue Cross Reactivity Screening (frozen TMA or a restricted range of full-face tissues)
Phase 2: GLP Tissue Cross-Reactivity Study (full scale assay – 36 full-face human tissues, each from 3 donors).
The benefits of the Asterand approach are:
- Access to high quality human tissues suitable for use in the analysis of tissue cross reactivity
- Fully trained Study Directors, with years of experience in immunohistochemistry
- GLP compliant Quality Management system
- Phase 1b screening of candidate antibodies prior to a Phase 2 GLP study allows cost-effective, confident 'Go/No-Go' decisions on the selection of candidates
For further information, contact us at customerservice@asterand.com
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