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font-size: 12px; color: #BE0000; font-family: Arial, Helvetica, sans-serif; text-indent: 35pt;">Antibody Validation</a></td> </tr> <tr> <td height="23" ><!--class="FR_Menu2" onmouseover="this.className='FR_Menu_Over';" onmouseout="this.className='FR_Menu';"--> <div class="IMG_Left"><img src="../images/space.gif" name="img_02" width="6" height="6" id="img14" /></div><a href="../target_validation/atuoradio.htm" style="font-weight: bold; font-size: 12px; color: #BE0000; font-family: Arial, Helvetica, sans-serif; text-indent: 35pt;">Autoradiography</a></td> </tr> <tr> <td height="10"></td> </tr> <tr> <td height="30" class="FR_Menu" onmouseover="this.className='FR_Menu_Over';" onmouseout="this.className='FR_Menu';"><div class="IMG_Right"><img src="../images/space.gif" name="img_02" width="6" height="6" id="img15" /></div><a href="../target_validation/core.htm" >Core Capabilities</a></td> </tr> </table> <td style="width: 990px"> <table> <tr> <td style=" width: 600px"> <div id="Padding3"> <h1>Tissue Cross-Reactivity Studies-GLP</h1> </div> </td> <td><img alt="GryDiv" src="../images/GLP-TCR-Logo-small.jpg" /></td> </tr> </table> <p>Asterand's Molecular Pathology team provides complete and comprehensive GLP-Compliant Tissue Cross-Reactivity (TCR) Studies for the assessment of biotherapeutic agents following the U.S. Federal Drug Administration (FDA) and European Medicines Agency (EMA) guidelines. Our laboratory is equipped for moderate-throughput, automated immunohistochemistry (IHC) and is a member of the UK Good Laboratory Practice (GLP) Compliance Monitoring program.</p> <p><b>GLP Tissue Cross-Reactivity Study Solutions</b> <br /> Our Molecular Pathology team is comprised of fully trained study directors, scientists and pathologists with over 10 calendar years' experience in optimizing and performing IHC assays. This experience and expertise, together with the addition of our GLP compliant laboratory, is complemented by access to our extensive human tissue biorepository and unparalleled worldwide network of donor institutions. Our expertise and access to tissues enables the efficient delivery of high quality data, with full reporting, to support our clients in their submissions to the FDA or EMA.</p> <p>Asterand's complete tissue list for GLP tissue cross-reactivity studies contains 36 tissue types which include all the tissue types required by both the FDA and EMA:</p> <table align="center" width="720px"> <tr valign="top"> <td style="height: 50px"> <table align="center" width="750px"> <tr align="left"> <td valign="top" style="width: 200px"> <ul> <li>Adrenal gland</li> <li>Bladder</li> <li>Blood cells</li> <li>Blood vessels - endothelium</li> <li>Bone marrow</li> <li>Breast</li> <li>Cerebellum</li> <li>Cerebral cortex</li> <li>Colon</li> </ul> </td> <td valign="top" style="width: 200px"> <ul> <li>Ileum</li> <li>Eye</li> <li>Fallopian tube</li> <li>Heart</li> <li>Kidney - glomerulus & tubule</li> <li>Liver</li> <li>Lung</li> <li>Lymph node</li> <li>Ovary</li> </ul> </td> <td valign="top" style="width: 172px"> <ul> <li>Pancreas</li> <li>Parathyroid gland</li> <li>Parotid salivary gland</li> <li>Peripheral nerve&nbsp; </li> <li>Pituitary gland</li> <li>Placenta</li> <li>Prostate</li> <li>Skeletal muscle</li> <li>Skin</li> <li>Spinal cord</li> </ul> </td> <td valign="top" style="width: 169px"> <ul> <li>Spleen</li> <li>Stomach</li> <li>Testis</li> <li>Thymus</li> <li>Thyroid gland</li> <li>Tonsil</li> <li>Ureter</li> <li>Uterus  cervix, endometrium </li> </ul> </td> </tr> </table> </td> </tr> </table> <p><b>&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;<img id="Img2" alt="" src="../target_validation/PhzChrt2.jpg" /></b></p> <p>All tissues are acquired according to Asterand's well established ethics, consent and quality protocols and stored in Asterand's repository for immediate access.</p> <p>The GLP Tissue Cross-Reactivity Study is performed using the optimized protocols and conditions established in Phase 1a. Asterand recommends that a TCR screen (Phase 1b) be performed prior to the GLP TCR Study. This screening will enhance confidence in the validated protocol defined in Phase 1a and allow informed biotherapeutic agent selection for analysis under GLP.</p> <p>The protocol outline of a complete GLP Tissue Cross-Reactivity Study now available to our clients is as follows:</p> <p> <strong>Phase 1a: Tissue Cross-Reactivity Automated Assay optimization / validation </strong> </p> <ul> <li>Frozen full-face tissue sections or sections taken from cytospins prepared from cell lines or primary cells (specified by client or as suggested by Asterand)</li> <li>Positive and negative control tissues and/or primary cells / cell lines</li> <li>Two tissue fixation protocols, three primary antibody concentrations</li> <li>Non-immune IgG negative controls</li> <li>Assay control: FITC-conjugated or biotinylated anti-beta actin</li> <li>Tabular report recommending optimal IHC conditions</li> </ul> <p> <p> <strong>Phase 1b: TCR Screening on Frozen Tissue Microarrays</strong> </p> <ul> <li>Each Tissue Microarray (TMA) is made up of 12 tissue types each, n=3 donors, with duplicate cores per donor</li> <li>Frozen sections taken from each TMA, consisting of 72 cores, each of 2mm in diameter</li> <li>Positive and negative control tissues (as full face sections) run alongside</li> <li>One fixation protocol (established in Phase 1a)</li> <li>One primary antibody concentration (established in Phase 1a)</li> <li>Matching non-immune IgG isotype negative control <li>Full assay automation</li> <li>Full data analysis and reporting of results</li> <li>Asterand does not recommend conducting this Phase under GLP conditions</li> </ul> <p> <strong>Phase 2: GLP Tissue Cross-Reactivity Study </strong> <ul> <li>Frozen, full-face tissue sections</li> <li>Positive and negative control tissues</li> <li>One fixation protocol (established in Phase 1a)</li> <li>One primary antibody concentration (established in Phase 1)</li> <li>Matching non-immune IgG isotype negative control</li> <li>Assay automation </li> <li>Assay control</li> <li>Reviewed by Consultant Histopathologist</li> <li>Scoring of signal intensity and generation of tabulated report illustrated with annotated photomicrographs</li> </li> </ul> <br /> <p> For further information, contact us at <a id="a4" href="mailto:advantage@asterand.com?subject=Tissue Cross-Reactivity Studies Inquiry"><span style="color: #0000ff">advantage@asterand.com</span></a>.</p> </td> </tr> </table> <br /> <table align="center" width="1000" border="0" cellspacing="0" cellpadding="0"> <tr valign="middle"> <td style="font-size: 8pt; color: gray; font-family: Tahoma; width: 900px;" align="left"> <font style="font-size: 10px; color: gray; font-family: Tahoma;">© 2010 Asterand plc. 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