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With over a decade of experience of conducting client-sponsored immunohistochemical (IHC) studies on human tissues, Asterand is a leading provider of Tissue Cross Reactivity (TCR) services on biotherapeutics to Good Laboratory Practice (GLP). Our team of Study Directors and Pathologists ensure that your project will be handled with the upmost care and attention to timelines. Quality at Source We realize your confidence in TCR study results is greatly affected by the quality of the tissues used. Asterand's extensive human tissue biorepository and supporting tissue supply network allows immediate access to all of the tissue types required by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for TCR safety studies. Because we manage our own tissue network and have a team of board certified pathologists, we are able to provide our clients with the assurance that the well characterized tissues used for your studies are of the utmost quality.A Portfolio of Services to Meet Your Requirements Asterand's Molecular Pathology team, based at our UK facility, will provide a custom service to meet your particular requirements for your biotherapeutic agent. We offer biotherapeutic validation studies that provide a cost effective solution for making confident decisions on the suitability and parameters (e.g. concentration, methodology) to deploy for your biotherapeutic agent and so minimize the risk of GLP study failure. We generate data in compliance with GLP for instance for biotherapeutic candidates as part of an Investigational New Drug Application to the FDA.Our Three Phase Approach Phase 1a: Tissue Cross-reactivity assay optimization using positive/negative control tissues. We will work with you to select and if necessary provide suitable tissue (whether normal or diseased) or cell cytospins to deploy in the validation of your biotherapeutic agent. Further optimization studies can be performed, such as peptide blocking or Western blotting, if required.Phase 1b:TCR pre-screening with Tissue Microarrays We have available high quality frozen tissue microarrays (TMAs) for the initial profiling of your biotherapeutic candidate which may be utilised as a cost-effective 'look see' approach for instance where you have a choice of candidates. Phase 2: GLP TCR Study on FDA/EMA-recommended tissue sections Utilizing a fully validated automated IHC platform and the expertise of our trained pathologists, we will undertake your GLP TCR study with close attention to scientific rigor, timeliness and thoroughness. Advantages of Choosing Asterand for your Studies
To learn more about our tissue cross reactivity services, contact us to request a quote or a copy of our GLP Services brochure. |
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