Accredited with GLP Regulatory status since 2005
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.
For a GLP regulatory study, a working IHC assay is developed using appropriate control material. This assay is then applied to 38 frozen human tissues from 3 donors, to cover both FDA and EMA regulatory guidelines. The study is audited by a quality assurance consultant.
The team at Histologix have many combined years of experience in regulatory Tissue Cross-Reactivity (TCR) studies 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 a considerable depth of knowledge of all these therapeutics allowing us to achieve successful TCR outcomes.
HistologiX can also offer non-regulatory screening which is useful when trying to identify lead candidate antibodies or clones using reduced numbers of tissue samples or Tissue Micro-Arrays. Using tissues from animal species and the IHC procedures described it is possible to identify the most appropriate laboratory species in which to undertake preclinical toxicology studies. This is also strongly suggested by the various regulatory authorities.