Histologix presented its interpretation of the TCR “Points to Consider” guidelines to the FDA in 1992 and it is those protocols that have since become universally accepted as the basis for current TCR study designs today.
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.
The Team at Histologix have over 60 years of combined experience in regulatory 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.
Regulatory TCR studies consist of two phases. The first being where the conditions under which the antibody is to be used are optimised and where a working IHC assay is developed using appropriate control material and the second phase comprises of the actual screening of human tissue samples from approximately 38 tissues from 3 donors to cover both FDA and EMA regulatory guidelines.
HistologiX can also offer non-regulatory screening which is useful when trying to identify lead candidate antibodies or clones using reduced numbers of tissues 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.
Histologix provides the Pharmaceutical and Biotechnology industry with specialist pathology services to assist drug development programmes ranging from Discovery, regulatory preclinical safety testing through to clinical trials and include human tissue sourcing, histology, medical and veterinary histopathology, immunohistochemistry, digital pathology and image analysis. These are technologies that have been developed with to meet current and future requirements of targeted therapy.
Through inward investment the services provided by Histologix Ltd use a range of highly sophisticated technologies and platforms aimed at standardising the various processes involved in order to achieve data generation that is consistent, accurate and reproducible and will assist our clients in the development of their drug programmes.
Histologix is a privately owned contract research organisation that provides specialist pathology services for the Pharmaceutical and Biotechnology industry. Set up in 2005 by industry specialists, Histologix is a GLP/GCP accredited, HTA-licenced company with an extensive and impressive track record of successfully delivering a range of IHC/ISH assays to large and small Pharma/Biotechnology companies and is a preferred supplier of these services to a number of companies.
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