mRNA-LNP Solutions

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• <p> <span style="font-size: 18px">㈜웰진은 mRNA-LNP Solution의 품질 특성과 요구사항을 기반으로 시험항목, 시험방법 및 결과 기록을 체계적으로 구성한 문서를 제공합니다.</span> </p> <p> <span style="font-size: 18px">본 문서는 연구개발, 공정 개발 및 품질관리 전반에 걸쳐 활용할 수 있도록 구성되었습니다. </span> </p> <p> <br> </p> <p> <span style="color: #0000ff"><b><span style="font-size: 20px; color: #0000ff">QC 항목</span></b></span> </p> <p> </p> <table cellpadding="1" cellspacing="0" style="border-color: #000000; border-style: solid; border-width: 1px; border-collapse: collapse; width: 100%"> <tbody> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"><b>No.</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> <b>시험 항목</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> <b>시험 방법</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"><b>시험 목적 </b></span> </td> </tr> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"><b> 1</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Appearance</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Visual Inspection</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> 외관 확인</span> </td> </tr> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> <b>2</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Particle Size</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Dynamic Light Scattering (DLS)</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> mRNA-LNP 입자 크기 확인</span> </td> </tr> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> <b>3</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> PDI</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Dynamic Light Scattering (DLS)</span><span style="font-size: 18px"> </span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> mRNA-LNP 입자 균일성 평가</span> </td> </tr> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> <b>4</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Zeta Potential</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Electrophoretic Light Scattering (ELS)</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 12px"> </span><span style="font-size: 18px">mRNA-LNP 입자 표면 전하 측정</span> </td> </tr> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"><b> 5</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Encapsulation Efficiency</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> RiboGreen Assay</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> mRNA 포집 효율 평가 </span> </td> </tr> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> <b>6</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> mRNA Concentration</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> UV 또는 Fluorescence</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> 포집된 mRNA 농도 확인</span> </td> </tr> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> <b>7</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> mRNA Integrity</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Bioanalyzer</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> 포집된 mRNA 안정성 확인</span> </td> </tr> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> <b>8</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> pH</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> pH Meter 또는 pH Paper</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> mRNA-LNP 입자의 pH 확인</span> </td> </tr> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> <b>9</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Bioburden</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Direct Inoculation</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> mRNA-LNP 입자의 미생물 오염 수준 확인</span> </td> </tr> <tr> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> <b>10</b></span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> Endotoxin</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> LAL Test</span> </td> <td style="border-style: solid; border-width: 1px; border-color: #000000"> <span style="font-size: 18px"> mRNA-LNP 입자의 엔도톡신 확인</span> </td> </tr> </tbody> </table> <br><p> <span style="font-size: 18px">㈜웰진은 Particle Size, Encapsulation Efficiency, Bioburden, Endotoxin 등 mRNA-LNP Solution의 주요 품질 항목을 포함한 QC 문서를 통해 효율적인 업무를 지원합니다.</span> </p>
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