Biotherapeutic safety
Guidelines issued by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the development of therapeutic antibodies and related products continue to recommend testing novel biotherapeutics for potential off-target binding (tissue cross-reactivity, TCR) on a range of human tissues.
Pharmagene’s scientific team perform both non-GLP TCR screening studies using frozen tissue microarrays (TMA) and GLP-compliant TCR studies suitable for Investigational New Drug (IND) submission.
Tailored methodology for biotherapeutic tissue cross-reactivity studies
Our unique combination of research services and comprehensive tissue bank underpin the delivery of our TCR Services.
Tissue cross-reactivity study services
Combined with a scientific approach for each novel test molecule, our expertise in immunohistochemistry (IHC) assay development for a broad range of biotherapeutic modalities enables us to deliver high-quality data to our clients in a defined time period.
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Robust assay development and optimisation
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TCR screening using frozen tissue microarrays for rapid data delivery prior to fully GLP-compliant studies
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GLP tissue cross-reactivity studies utilising all 36 required human tissue types
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Confirmation of tissue antigenicity
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Fully automated IHC assays
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Medicines and Healthcare products Regulatory Agency (MHRA) GLP-certified facility
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Expert pathologist review and reporting
Qualified biospecimens for tissue cross-reactivity studies
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Robust qualification of tissues from procurement to assay use
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Non-GLP tissue microarray (TMA)
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GLP full-face sections of 36 human tissue types
Tissue types available for GLP TCR studies
Pharmagene has developed, and maintains, a well-curated, dedicated panel of high-quality frozen human tissues to deliver TCR studies. All human tissues recommended for TCR testing by the FDA and the EMA are fully consented for commercial research, and available from at least 3 male and 3 female donors.
Adrenal gland | Ileum | Prostate |
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Bladder | Kidney – glomerulus and tubule | Skeletal muscle |
Blood cells | Liver | Skin |
Blood vessel endothelium | Lung – bronchus and parenchyma | Spinal cord |
Bone marrow | Lymph node | Spleen |
Breast | Ovary | Stomach |
Cerebellum | Pancreas | Testis |
Cerebral cortex | Parathyroid gland | Thymus |
Colon | Parotid salivary gland | Thyroid gland |
Eye | Peripheral nerve | Tonsil |
Fallopian tube | Pituitary gland | Ureter |
Heart | Placenta | Uterus – cervix and endometrium |
Expertise to develop robust tissue binding assays for a range of biotherapeutic modalities
Over the past 15 years, we have delivered GLP TCR data supporting the safety assessment of a range of novel biotherapeutics. Each test molecule has its own specific requirements for assay development and optimisation, including identification or preparation of specific assay controls, depending on the drug target(s).
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Monoclonal antibodies
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Mono- bi- & tri-specific binding molecules (small antibody-like)
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scFv fragments
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Antibody-drug conjugates
Pharmagene’s 3-phase approach to TCR testing
Pharmagene’s 3-phase approach to TCR testing