Antibodies intended for therapeutic clinical use must undergo regulatory screening in human tissue as part of any preclinical safety assessment in line with US FDA, EU and Japanese MAFF regulations.
As part of a range of pre-clinical investigations, tissue cross-reactivity (TCR) studies are required for Investigational New Drug and Clinical Trials Application submissions. These studies are conducted to identify off-target binding, and potentially to identify unexpected on-target binding which may lead to toxicity or improved efficacy in vivo.
HistologiX offers GLP-compliant TCR studies in which an immunohistochemical (IHC) assay is developed using appropriate control material and audited by our internal quality assurance team.
We are also able to conduct screening to identify lead candidates, in a reduced tissue number, or by making use of a ‘tissue micro-array’ (TMA). TMAs contain representative samples from a large number of tissues and donors and are an efficient means of performing initial screens in human tissue.
We have many years of experience conducting TCR studies and screens, and have successfully optimised IHC assays for a range of novel antibody classes including; murine, humanised, chimeric, fully human, antibody cocktails, Fab/VH fragments, bispecific superantigens, biomers, tetramers, nanobodies, multispecific nanobodies, aptamers, and variable regions attached to various carrier backbones. Each type of molecule has its own characteristics and HistologiX has considerable knowledge of all these therapeutics allowing us to achieve successful TCR outcomes.
With 100+ years of combined experience, we offer Good Laboratory Practice (GLP) Tissue Cross Reactivity (TCR) studies for your biotherapeutic on a range of human tissues suitable for Investigational New Drug (IND) and Clinical Trials Application submissions.
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