Fresenius Kabi Lovo

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Selection Prep</li> <li data-target="app-fresh">Fresh Leukapheresis Wash</li> <li data-target="app-culture">Culture Harvest & Media Exchange</li> <li data-target="app-thawed">Thawed Wash & DMSO Removal</li> </ul> </div> </div> </div> </div>  <div id="app-immu" class="section-applications"> <div class="container"> <div> <div class="info-content"> <div class="page-label">Applications</div> <div class="icon-title"> <div><img src="/wp-content/uploads/2018/02/Icon-ISP.png" alt=""></div> <div> <h2>Immunomagnetic Selection Prep</h2> </div> </div> <p class="desc">Lovo can automate preparation for magnetic selections, simplifying and expediting day 0 processing. With Lovo 3.0 software, you have the option to incorporate mid-procedure, timed incubations in your protocol design.</p>  </div> </div> <div> <ul class="tabs"> <li data-tab="immu-tab-0" class="tab active">Overview</li> <li data-tab="immu-tab-1" class="tab">Data</li> </ul> <div id="immu-tabs"> <div id="immu-table" class="tab-content table active"> <table> <tr> <th colspan="2" class="bg-gray">Measure</th> <th class="bg-dark-blue">Result</th> </tr>  <tr> <td rowspan="4" class="label bd-solid">Source Products</td> <td class="bd">Collections</td> <td class="bd bg-lg tc">n=5</td> </tr> <tr> <td class="bd-solid">Volume</td> <td class="bd-solid bg-lg tc">163.3 <span>±</span> 28.5 mL</td> </tr> <tr> <td class="bd-solid">Total Nucleated Cells (TNC)</td> <td class="bd-solid bg-lg tc">10.9 <span>±</span> 3.4 x 10<sup>9</sup></td> </tr> <tr> <td class="bd-solid">Platelet Count</td> <td class="bd-solid bg-lg tc">4.46 <span>±</span> 0.92 x 10 <sup>11</sup></td> </tr>  <tr> <td rowspan="2" class="label bd-solid">Processing Time</td> <td class="bd">Automated Processing Time (With incubation)</td> <td class="bd bg-lg tc">58 minutes</td> </tr> <tr> <td class="bd-solid">Max Processing Time</td> <td class="bd-solid bg-lg tc"> 61 minutes</td> </tr> </table> <p class="step small mt15">Source: LOVO 2.X Blood Run Protocol Report: 223-DER-048957 – Data on file at Fresenius Kabi USA.</p> </div> <div id="immu-table2" class="tab-content table"> <table> <tr> <th colspan="2" class="bg-gray">Measure</th> <th class="bg-dark-blue">Result</th> </tr>  <tr> <td rowspan="3" class="label bd-solid">2 wash cycles to remove platelets and prepare for incubation</td> <td class="bd">Platelet Depletion</td> <td class="bd bg-lg tc">98.4 <span>±</span> 1.0%</td> </tr> <tr> <td class="bd-solid">Targeted Pre-Incubation Volume</td> <td class="bd-solid bg-lg tc">100 mL</td> </tr> <tr> <td class="bd-solid">Actual Pre-Incubation Volume</td> <td class="bd-solid bg-lg tc">100.6 <span>±</span> 1.2 mL</td> </tr>  <tr> <td rowspan="2" class="label bd-solid">Full Procedure</td> <td class="bd">TNC recovery</td> <td class="bd bg-lg tc">97.2 <span>±</span> 3.7%</td> </tr> <tr> <td class="bd-solid">TNC Viability</td> <td class="bd-solid bg-lg tc">96.3 <span>±</span> 1.4%</td> </tr> </table> <p class="step small mt15">Source: LOVO 2.X Blood Run Protocol Report: 223-DER-048957 – Data on file at Fresenius Kabi USA.</p> </div> </div> </div> </div> </div>  <div id="app-fresh" class="section-applications section-bg-gray"> <div class="container"> <div> <div class="info-content"> <div class="page-label">Applications</div> <div class="icon-title"> <div><img src="/wp-content/uploads/2018/02/Icon-FLW.png" alt=""></div> <div> <h2>Fresh Leukapheresis Wash</h2> </div> </div> <p class="desc">Quickly and easily remove platelets from leukapheresis products while recovering TNCs and maintaining cell viability.</p> </div> </div> <div> <ul class="tabs"> <li data-tab="fresh-tab-0" class="tab active">Overview</li> <li data-tab="fresh-tab-1" class="tab">Data</li> </ul> <div id="fresh-tabs"> <div id="fresh-table" class="tab-content table active"> <table> <tr> <th colspan="2" class="bg-gray">Measure</th> <th class="bg-dark-blue">Result</th> </tr>  <tr> <td rowspan="2" class="label bd-solid">Collections <br><span>(5L)</span></td> <td class="bd">Fenwal Amicus</td> <td class="bd bg-lg tc">n=6</td> </tr> <tr> <td class="bd-solid">Spectra Optia</td> <td class="bd-solid bg-lg tc">n=8</td> </tr>  <tr> <td rowspan="2" class="label bd-solid">Source</td> <td class="bd">Volume</td> <td class="bd bg-lg tc">90.8 <span>±</span> 10.2 ml</td> </tr> <tr> <td class="bd-solid">TNC</td> <td class="bd-solid bg-lg tc">4.7 <span>±</span> 1.8 x 10<sup>9</sup></td> </tr>  <tr> <td rowspan="4" class="label bd-solid">Final <br>Product</td> <td class="bd">TNC Recovery</td> <td class="bd bg-lg tc">98.6%</td> </tr> <tr> <td class="bd-solid">TNC Viability</td> <td class="bd-solid bg-lg tc">97.5%</td> </tr> <tr> <td class="bd">Target Final Volume</td> <td class="bd bg-lg tc">95 mL</td> </tr> <tr> <td class="bd-solid">Actual Final Volume</td> <td class="bd-solid bg-lg tc">95.3 <span>±</span> 0.6 mL</td> </tr>  <tr> <td rowspan="2" class="label bd-solid">Processing Time</td> <td class="bd">Average</td> <td class="bd bg-lg tc">11:01 min</td> </tr> <tr> <td class="bd-solid">Maximum</td> <td class="bd-solid bg-lg tc">11:29 min</td> </tr> </table> <p class="step small mt15">Source: LOVO 2.X Product Quality Test Results Design Review: 223-DER-048958 – Data on file at Fresenius Kabi USA.</p> </div> <div class="tab-content"> <p class="step">Pre/Post Lovo Wash Platelet Count & Depletion</p> <p><img src="/wp-content/uploads/2018/02/Graph-Viability.png" alt=""></p> <p class="step small mt15">Source: LOVO 2.X Product Quality Test Results Design Review: 223-DER-048958 – Data on file at Fresenius Kabi USA.</p> </div> </div> </div> </div> </div>  <div id="app-culture" class="section-applications"> <div class="container"> <div> <div class="info-content"> <div class="page-label">Applications</div> <div class="icon-title"> <div><img src="/wp-content/uploads/2018/02/Icon-CHME.png" alt=""></div> <div> <h2>Culture Harvest & Media Exchange</h2> </div> </div> <p class="desc">Quickly and easily wash and concentrate up to 22L of cultured cells in one automated and functionally closed system.</p> <P class="desc noMB"><strong>Study objective</strong></P> <ul class="desc"> <li>Compare T-Cell harvest methods</li> </ul> <p class="desc noMB"><strong>Goals</strong></p> <ul class="desc"> <li>Reduce volume from 1.7L to 150mL</li> <li>>99% (2 log) reduction of ancillary materials</li> <li>High cell recovery</li> <li>Maintain cellular CQAs</li> </ul> </div> </div> <div> <div id="culture-tabs"> <div id="culture-table" class="tab-content table active"> <table> <tr> <th class="bg-gray">Cell Type</th> <th class="bg-dark-blue m-line">Lovo <br> <span>Fresenius Kabi</span></th> <th class="bg-gray m-line">CS5+ <br> <span>Haemonetics</span></th> <th class="bg-gray">Manual</th> </tr> <tr> <td class="label bd-solid">Recovery <span>(%)</span></td> <td class="bg-lg bd-solid tc">93 <span class="pm">±</span> 4</td> <td class="bd-solid tc">87 <span class="pm">±</span> 3</td> <td class="bd-solid tc">91 <span class="pm">±</span> 4</td> </tr> <tr> <td class="label bd-solid">Processing Time <span>(min)</span></td> <td class="bg-lg bd-solid tc">30 <span class="pm">±</span> 1</td> <td class="bd-solid tc">25 <span class="pm">±</span> 4</td> <td class="bd-solid tc">61 <span class="pm">±</span> 11</td> </tr> <tr> <td class="label bd-solid">Washout Efficiency <span>(%)</span></td> <td class="bg-lg bd-solid tc">99.5</td> <td class="bd-solid tc">99.9</td> <td class="bd-solid tc">99.8</td> </tr> <tr> <td class="label bd-solid">Final Volume <span>(mL)</span></td> <td class="bg-lg bd-solid tc">150 <span class="pm">±</span> 1</td> <td class="bd-solid tc">153 <span class="pm">±</span> 3</td> <td class="bd-solid tc">151 <span class="pm">±</span> 6</td> </tr> <tr> <td class="label bd-solid">Cellular CQAs<sup>1</sup></td> <td colspan="3" class="bg-lg bd-solid tc">comparable</td> </tr> <tr> <td class="label bd-solid">Automated</td> <td class="bg-lg bd-solid tc check-corss">✓</td> <td class="bd-solid tc check-corss"><span style="font-size: 30px;">±</span></td> <td class="bd-solid tc check-corss">x</td> </tr> <tr> <td class="label bd-solid">Functionally Closed</td> <td class="bg-lg bd-solid tc check-corss">✓</td> <td class="bd-solid tc check-corss"><span style="font-size: 30px;">±</span></td> <td class="bd-solid tc check-corss">x</td> </tr> </table> <p class="step small mt15">1 Critical Quality Attributes (CQAs) Measured: viability assessment, phenotype, cell functionality, ancillary materials. <br><br>Source: Lovo New Membrane Cultured Cell Testing Results: 223-DER-066723 – Data on file at Fresenius Kabi USA.</p> </div> </div> </div> </div> </div>  <div id="app-thawed" class="section-applications section-bg-gray"> <div class="container"> <div> <div class="info-content"> <div class="page-label">Applications</div> <div class="icon-title"> <div><img src="/wp-content/uploads/2018/02/Icon-DMSO.png" alt=""></div> <div> <h2>Thawed Wash & DMSO Removal</h2> </div> </div> <p class="desc">Wash cryopreserved products and resuspend cells in your preferred buffer or culture media.</p> </div> </div> <div> <ul class="tabs"> <li data-tab="thawed-tab-0" class="tab active">Overview</li> <li data-tab="thawed-tab-1" class="tab">Data</li> </ul> <div id="thawed-tabs"> <div id="thawed-table" class="tab-content table active"> <table> <tr> <th class="bg-gray">Measure</th> <th class="bg-dark-blue m-line">Lovo 2.0<br><span>(three-cycle)</span></th> </tr> <tr> <td class="label bd-solid">Number of Runs</td> <td class="bd-solid tc">6</td> </tr> <tr> <td class="label bd-solid">PCV%</td> <td class="bd-solid tc">8.4% (6.9 - 11.4)</td> </tr> <tr> <td class="label bd-solid">Viable CD34+ Cell Recovery</td> <td class="bd-solid tc">84% (61 - 93)</td> </tr> <tr> <td class="label bd-solid">CD34+ Cell Viability</td> <td class="bd-solid tc">92% (81 - 94)</td> </tr> <tr> <td class="label bd-solid">DMSO Elimination</td> <td class="bd-solid tc">97% (97 - 98)</td> </tr> <tr> <td class="label bd-solid">Total Processing Time</td> <td class="bd-solid tc">62 min</td> </tr> </table> <p class="step small mt15">† Data is expressed as median and (IQR)<br><br> Source: B.Mfarrej, et al. Pre-clinical assessment of the Lovo device for dimethyl sulfoxide removal and cell concentration in thawed hematopoietic progenitor cell grafts. Cytotherapy, Volume 19, Issue 12, 1501-1508.</p> </div> <div class="tab-content"> <p class="step noPB">3-Cycle Wash<sup>1</sup></p> <p class="step small">Post Thaw Recovery</p> <p><img src="/wp-content/uploads/2018/02/TW_Tab2.png" alt=""></p> <p class="step small mt15">Source: B.Mfarrej, et al. Pre-clinical assessment of the Lovo device for dimethyl sulfoxide removal and cell concentration in thawed hematopoietic progenitor cell grafts. 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