![]() ![]() The content of the study report is based upon FDA recommendations and includes a signature page, executive summary, methods, materials, scoring table results, analysis, peer review and conclusions. a high quality antibody that exhibits minimal cross-reactivity should be employed. ![]() Prior to staining, we undertake an assessment of tissue integrity to confirm that each tissue within the panel has been handled correctly with no areas of necrosis or autolysis and optimal autogenicity and morphology is present.Įvaluation and scoring of the stained tissue panel by an experienced pathologist is highly beneficial – not only to ensure accurate assessment of target binding and distribution, but also to convey credibility during the regulatory submission process.Īll TCR studies at Propath are conducted under GLP conditions and under the direction of an experienced Study Director, are evaluated by an experienced pathologist (with or without a peer review), and undergo a study-specific QA audit to confirm GLP compliance. All steps of an IHC/ICC experiment must be optimized to visualize. Non-human tissues in addition to human tissues are often tested. The panel may be extended to include additional organs depending on the specific requirements of a study or to conform with EMA recommendations. This conforms with the recommendations in the FDA document, “Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use”. Within this phase, we assess cross-reactivity of the test article and its isotype control at three different dilutions, across triplicate specimens on a minimum of 33 human organs. Phase 2: TCR study in a full panel of tissues under GLP conditions ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |