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list-style-bullets"> <p>바이러스 벡터 생산은 복잡한 프로세스를 채택하여 제품 수명 주기 전반에 걸쳐 다양한 도전 과제를 야기합니다. 주요 문제는 생산 시스템 선택, 제품 품질 최적화 및 견고한 CMC 접근 방식을 가능하게 하는 표준화 구축과 관련됩니다.<br /> </p> <p>Thermo Fisher Scientific 바이러스 벡터 서비스(Viral Vector Service, VVS)는 바이러스 벡터 및 유전자 기반 백신의 개발 및 상용화를 위한 모든 서비스를 제공하는 선도적인 CDMO서비스입니다. 당사의 바이러스 벡터 end-to-end 역량에는 공정 및 분석 개발, 임상 및 상업용 제조, 충전/완제 서비스가 포함됩니다. 광범위한 생산시설 네트워크, 글로벌 임상 공급망, 그리고 심층적인 바이러스 벡터 기술 및 규제 전문성을 통해, 당사는 치료제의 개발 여정에서 위험을 제거하고 출시 일정을 앞당길 수 있습니다.</p> </div> </div> <div class="cmp-button aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--6"> <div id="button-1786748183" class="btn-wrapper"> <a class=" btn btn-style-primary icon-placement-left " href="https://www.patheon.kr/about-us/contact-us/contact-form" role="button" target="_self"> 문의하기 </a> </div> <style> #button-1786748183 .btn-style-quickLink { border-left: 6px solid #1E8AE7; } #button-1786748183 { padding-right:0px; padding-left:0px; } </style> </div> </div> </div> <style type="text/css"> 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aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div class="takeaways-wrapper"> <div class="takeaway-card" style="color: #ED7700; border-color: #ED7700"> <i class="fak fa-patheon-calendar icon icon"></i> <div class="main-text"></div> <div class="sub-text"><h4><b><span style="color: rgb(237,119,0);" class="p-class">20+ years</span></b></h4> <p class="p-claim">20년 이상의 바이러스 벡터 개발, 생산 경험</p> </div> </div> <div class="takeaway-card" style="color: #ED7700; border-color: #ED7700"> <i class="fak fa-patheon-case-study icon"></i> <div class="main-text"></div> <div class="sub-text"><h4><b><span style="color: rgb(237,119,0);">2 commercially approved products</span></b></h4> <p class="p-claim">2개 약물 상용 승인 지원</p> </div> </div> <div class="takeaway-card" style="color: #ED7700; border-color: #ED7700"> <i class="fak fa-globalbrand-dna icon"></i> <div class="main-text"></div> <div class="sub-text"><h4><b><span style="color: rgb(237,119,0);" class="p-claim">700+ lots</span></b></h4> <p>700개 이상의 로트 제조</p> </div> </div> <div class="takeaway-card" style="color: #ED7700; border-color: #ED7700"> <i class="fak fa-globalbrand-manufacturing icon"></i> <div class="main-text"></div> <div class="sub-text"><h4><b><span style="color: rgb(237,119,0);">50+</span></b></h4> <p class="p-claim">50개 이상의 DS 제조소 및 12개 DP 제조소</p> </div> </div> </div> </div> <div class="cmp-container aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner py-5 pb-0 " id="container-1249158070"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> </div> </div> <style type="text/css"> #container-1249158070{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1249158070 { border-radius: px; } </style> </div> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn aem-GridColumn--default--12"> <div id="text-404d5475f3" class="cmp-text list-style-bullets"> <p style="font-size: 22.0px;color: rgb(34,34,34);"><b>초기 발견에서 상업 생산까지, 전문성과 경험에 기반한 경로 설계</b></p> </div> </div> <div class="text aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div id="text-cdd5fc26e9" class="cmp-text list-style-bullets"> <p>당사는 바이러스 벡터 제조 서비스 외에도 약물 개발 및 제조 여정의 모든 단계를 지원하는 업스트림 및 다운스트림 서비스도 제공합니다. 소규모 프로세스를 최적화하는 중개 연구 (Translational services) 부터 최종 약물의 안전한 보관 및 유통을 위한 <a href="https://www.patheon.kr/our-capabilities/clinical-trial-services/cold-chain-management-logistics">콜드 체인 물류</a>에 이르기까지, 당사는 고객의 유전자 치료제 및 유전자 변형 세포 치료제를 관리하기 위한 전주기 솔루션을 제공합니다.</p> </div> </div> <div class="cmp-well aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div class="well " id="well-1384608010"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="image aem-GridColumn aem-GridColumn--default--12"> <link rel="stylesheet" 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id="text-3cadd6943d" class="cmp-text list-style-bullets"> <p>당사의 suspension 및 adherent 공정은 cGMP 바이러스 벡터 공정 개발에 대한 전문성을 바탕으로 고객의 약물, 적응증 및 배송 경로에 맞게 맞춤화할 수 있습니다. 당사는 다양한 규모의 공정 개발, 최적화, 스케일업, 기술 이전 및 GMP 제조에 대한 심층적인 경험을 보유하고 있으며, 유전자 치료제, 세포 치료제, 백신, 항암 바이러스, 비바이러스 벡터 및 면역요법과 같은 첨단 치료제 분야에서 700개 이상의 cGMP 배치를 성공적으로 생산했습니다.</p> </div> </div> <div class="cmp-container aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-717564172"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-56cb87d813" class="cmp-text list-style-bullets"> <h4><b>Vector production platforms and processes</b></h4> </div> </div> <div class="cmp-well aem-GridColumn aem-GridColumn--default--12"> <div class="well " style="background-position-x: center;background-position-y: center;" id="well-821832615"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-container aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-118803161"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-6ed942f101" class="cmp-text list-style-bullets"> <table cellspacing="0" border="1" style="border-top: none;border-left: none;border-right: none;border-bottom: none;" width="100%"> <tbody><tr><th style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);">ADENOVIRAL</th> <th width="2%" style="border: 0;"> </th> <th style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);">ADENO-ASSOCIATED VIRUS (AAV)</th> <th width="1%" style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);"> </th> <th style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);"> </th> <th width="1%" style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);"> </th> <th style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);"> </th> </tr><tr><td style="background: rgb(85,87,89);color: rgb(255,255,255);border-color: white;padding: 1.0%;">Adherent + Suspension</td> <td style="border: 0;"> </td> <td style="background: rgb(85,87,89);color: rgb(255,255,255);border-color: white;padding: 1.0%;">Producer cell line + Adv</td> <td style="border: 0;"> </td> <td style="background: rgb(85,87,89);color: rgb(255,255,255);border-color: white;padding: 1.0%;">Adherent + Suspension</td> <td style="border: 0;"> </td> <td style="background: rgb(85,87,89);color: rgb(255,255,255);border-color: white;padding: 1.0%;">Adherent + Suspension</td> </tr><tr><td style="background: rgb(201,200,200);padding: 1.0%;">Mammalian cells infection</td> <td style="border: 0;"> </td> <td style="background: rgb(201,200,200);padding: 1.0%;">Mammalian cells infection</td> <td style="border: 0;"> </td> <td style="background: rgb(201,200,200);padding: 1.0%;">Mammalian cells transient transfection</td> <td style="border: 0;"> </td> <td style="background: rgb(201,200,200);padding: 1.0%;">Insect cells – infection</td> </tr></tbody></table> <p> </p> <table cellspacing="0" border="1" style="border-top: none;border-left: none;border-right: none;border-bottom: none;" width="100%"> <tbody><tr><th style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);">LENTVIRAL (LV)</th> <th style="border: 0;" width="2%"> </th> <th style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);">RETROVIRAL (RV)</th> <th style="border-left: none;border-right: none;border-top: none;border-bottom: none;width: 2.0%;"> </th> <th style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);">HERPESVIRAL (HSV)</th> </tr><tr><td style="background: rgb(85,87,89);color: rgb(255,255,255);border-color: white;padding: 1.0%;">Adherent + Suspension</td> <td style="border: 0;"> </td> <td style="background: rgb(85,87,89);color: rgb(255,255,255);border-color: white;padding: 1.0%;">Adherent + Suspension</td> <td style="border: 0;"> </td> <td style="background: rgb(85,87,89);color: rgb(255,255,255);border-color: white;padding: 1.0%;">Adherent + Suspension</td> <td style="border: 0;"> </td> </tr><tr><td style="background: rgb(201,200,200);padding: 1.0%;">Mammalian cells transient transfection</td> <td style="border: 0;"> </td> <td style="background: rgb(201,200,200);padding: 1.0%;">Mammalian cells transient transfection</td> <td style="border: 0;"> </td> <td style="background: rgb(201,200,200);padding: 1.0%;">Mammalian cells infection</td> <td style="border: 0;"> </td> </tr></tbody></table> <p> </p> <table cellspacing="0" border="1" style="border-top: none;border-left: none;border-right: none;border-bottom: none;" width="100%"> <tbody><tr><th style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);">MODIFIED VACCINIA ANKARA (MVA)</th> <th style="border: 0;" width="2%"> </th> <th style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);">VESICULAR STOMATITIS VIRUS (VSV)</th> </tr><tr><td style="background: rgb(85,87,89);color: rgb(255,255,255);border-color: white;padding: 1.0%;">Suspension</td> <td style="border: 0;"> </td> <td style="background: rgb(85,87,89);color: rgb(255,255,255);border-color: white;padding: 1.0%;">Adherent</td> <td style="border: 0;"> </td> </tr><tr><td style="background: rgb(201,200,200);padding: 1.0%;">Infection + avian cell line</td> <td style="border: 0;"> </td> <td style="background: rgb(201,200,200);padding: 1.0%;">Infection + Mammalian cells transient</td> <td style="border: 0;"> </td> </tr></tbody></table> <p> </p> <table cellspacing="0" border="1" style="border-top: none;border-left: none;border-right: none;border-bottom: none;" width="49%"> <tbody><tr><th style="border-left: none;border-right: none;border-top: none;border-bottom-width: thick;border-bottom-color: rgb(231,19,22);color: rgb(231,19,22);">VIRUS-LIKE PARTICLES (VLP)</th> <td style="border: 0;"> </td> </tr><tr><td style="background: rgb(85,87,89);color: rgb(255,255,255);border-color: white;padding: 2.0%;">Suspension</td> </tr><tr><td style="background: rgb(201,200,200);padding: 2.0%;">Insect cell + Mammalian Infection</td> </tr></tbody></table> </div> </div> </div> </div> <style type="text/css"> #container-118803161{ background-image: url(''); background-color: rgba(247,247,247,0.74); background-size: cover; background-position: center; min-height: px; } #container-118803161 { border-radius: px; } </style> </div> </div> </div> </div> <style type="text/css"> #well-821832615 { border-radius: 0px; } </style> </div> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-7b9614b65e" class="cmp-text list-style-bullets"> <p>당사 팀은 위 플랫폼 외에도 다양한 바이러스 플랫폼 지원 경험을 보유하고 있습니다. 추가 역량에 대한 질문은 별도 <a href="https://www.patheon.kr/about-us/contact-us/contact-form" style="color: rgb(231,19,22);"><b>문의</b></a> 부탁드립니다.</p> </div> </div> </div> </div> <style type="text/css"> #container-717564172{ background-image: url(''); 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background-position: center; min-height: px; } #container-592767540 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--12"> <div class="cmp-container-inner py-3 cgmp-plasmid-dna-container " id="container-988740390"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-accordion aem-GridColumn aem-GridColumn--default--12"> <div class="accordion" id="manufacturing-capabilities"> <div class="accordion-item"> <div class="accordion-header" id="heading-manufacturing-capabilities"> <button class="accordion-button collapsed" type="button" data-bs-toggle="collapse" data-bs-target="#collapse-manufacturing-capabilities" aria-expanded="true" aria-controls="collapse-manufacturing-capabilities"> <span> <span class="accordion-title">제조 역량</span><br/> <span class="accordion-subtitle"></span> </span> </button> </div> <div id="collapse-manufacturing-capabilities" class="accordion-collapse collapse " aria-labelledby="heading-manufacturing-capabilities" data-bs-parent="#manufacturing-capabilities"> <div class="accordion-body"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--xlarge--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--xlarge--newline aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--default--none aem-GridColumn--xlarge--6 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12 aem-GridColumn--offset--xlarge--0 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner me-lg-3 me-md-0 " id="container-276044886"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--xlarge--6 aem-Grid--medium--12 "> <div class="text aem-GridColumn--xlarge--6 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div id="text-367ad7d9d0" class="cmp-text list-style-bullets"> <p>당사의 전용 바이러스 벡터 시설은 임상 및 상업 생산을 위한 cGMP 바이러스 벡터를 생산합니다. 50개의 원료의약품 제조실은 다양한 생산 모드 및 기술(Cell factories, iCELLis, SUB 등)에 사용될 수 있습니다. 반자동 및 완전 자동 충전 라인과 사전 검증을 거친 다양한 바이알 및 용기 마개 시스템을 사용하여, 종합적인 멸균 충전 및 완제 서비스를 제공합니다. 당사는 글로벌 기술 이전 전략을 통해 고객이나 내부 개발 및 파일럿 실험실에서 당사 시설로 프로세스를 성공적으로 이전하고 구축할 수 있도록 지원합니다. 승인 또는 밸리데이션된 방법을 이용한 공정 중, 출하 및 안정성 시험을 위해 각 시설에서 품질관리도 가능합니다.</p> </div> </div> <div class="text aem-GridColumn--xlarge--6 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--12"> <div id="text-e7db3c105b" class="cmp-text list-style-check"> <table cellpadding="1" cellspacing="1" style="border: solid;border-color: rgb(162,162,162);"> <tbody><tr style="background: rgb(247,247,247);"><td style="border: solid;border-color: rgb(162,162,162);background: rgb(38,34,98);color: rgb(255,255,255);"><p><b> </b></p> <center><b>Process characterization</b></center> <p> </p> </td> <td style="border: solid;border-color: rgb(162,162,162);background: rgb(38,34,98);color: rgb(255,255,255);"><p><b> </b></p> <center><b>MS&amp;T and process validation</b></center> <p> </p> </td> <td style="border: solid;border-color: rgb(162,162,162);background: rgb(38,34,98);color: rgb(255,255,255);"><p><b> </b></p> <center><b>Manufacturing</b></center> <p> </p> </td> <td style="border: solid;border-color: rgb(162,162,162);background: rgb(38,34,98);color: rgb(255,255,255);"><b><center>Quality control (QC)</center> </b></td> <td style="border: solid;border-color: rgb(162,162,162);background: rgb(38,34,98);color: rgb(255,255,255);"><p><b> </b></p> <center><b>Fill and finish</b></center> <p> </p> </td> </tr><tr style="background: rgb(235,242,250);"><td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Scale-down model qualification</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Manufacturing support studies</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Suspension and adherent modalities</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Compendial assay verification, assay qualification, and validation</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Formulation evaluation</td> </tr><tr style="background: rgb(235,242,250);"><td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Design of experiments (DoE)</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Process validation plan and strategy</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Clinical and commercial-scale capacity</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Drug substance and drug product in-process and batch release testing</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Semiautomated and automated fill lines (Bausch + Strobel, Optima)</td> </tr><tr style="background: rgb(235,242,250);"><td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Critical material expiration/lot variation studies</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Failure mode and effects analysis (FMEA)</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Broad range of technologies and equipment</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">cGMP stability studies</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Prequalified vial configurations</td> </tr><tr style="background: rgb(235,242,250);"><td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Mixing studies</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Validation support studies</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Cell and viral banking</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Reference Standard qualification</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Primary vial labeling and packaging</td> </tr><tr style="background: rgb(235,242,250);"><td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Critical quality attribute (CQA) analysis</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Technical transfer</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Process performance qualification (PPQ)</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Assay bridging and product comparability studies</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Up to 10,000 vial fill capacity per lot</td> </tr><tr style="background: rgb(235,242,250);"><td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Risk assessment</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);"> </td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Engineering runs for tech transfer and/or scale up</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);"> </td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);"> </td> </tr><tr style="background: rgb(235,242,250);"><td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Critical process parameters (CPPs), Key process parameters (KPPs)</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);"> </td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Up to 2,000L manufacturing batches</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);"> </td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);"> </td> </tr><tr style="background: rgb(235,242,250);"><td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);">Control strategy</td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);"> </td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);"> </td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);"> </td> <td style="border-left: solid;border-right: solid;border-color: rgb(162,162,162);padding-bottom: 0.5%;padding-left: 1.0%;padding-right: 1.0%;padding-top: 0.5%;background: rgb(238,238,238);color: rgb(85,87,89);"> </td> </tr></tbody></table> </div> </div> </div> </div> <style type="text/css"> #container-276044886{ background-image: url(''); background-color: ; background-size: cover; 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aem-GridColumn--default--12 aem-GridColumn--xsmall--10 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner equalizeHeights h-100" id="container-1746370308"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--xsmall--10 "> <div class="cmp-container aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--5 aem-GridColumn--xsmall--10 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner equalizeHeights h-100" id="container-1694029521"> <div class="aem-Grid aem-Grid--5 aem-Grid--small--5 aem-Grid--default--5 aem-Grid--xsmall--10 aem-Grid--medium--5 "> <div class="text aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--offset--default--0 aem-GridColumn--offset--medium--0 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--default--5 aem-GridColumn--xsmall--10"> <div id="text-9cf8307d51" class="cmp-text list-style-bullets"> <p> </p> <p>테스트 및 분석법 개발은 규제 요건에 부합하는 프로세스를 수립하고 생산하는 데 매우 중요합니다. 당사는 새로운 기술과 생산 역량에 지속적으로 투자함으로써 변화하는 규제 및 고객 요구에 빠르게 대응할 수 있었습니다. 일관된 실행 방법을 통해 배치 출하 시험을 간소화하여 제품 출하 일정을 앞당길 수 있습니다.</p> <p> </p> <p>각 바이러스 벡터 시설은 분석 테스트 및 품질관리 역량을 갖추고 있습니다. 임상 개발 및 상업적 규모 제조의 모든 단계에서, 당사의 전문가들은 차세대 분석 방법을 사용하고 품질 중심 프로세스로 개발 및 테스트를 지원함으로써 고객의 분석 요구를 지원합니다.</p> </div> </div> </div> </div> <style type="text/css"> #container-1694029521{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1694029521 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--newline aem-GridColumn aem-GridColumn--default--6 aem-GridColumn--xsmall--10 aem-GridColumn--offset--default--1"> <div 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background-position: center; min-height: px; } #container-1746370308 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn aem-GridColumn--default--12 aem-GridColumn--xsmall--10"> <div class="cmp-container-inner " id="container-1951767544"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-24f3ba9c84" class="cmp-text list-style-bullets"> <p> </p> <h4><a href="https://www.patheon.kr/insights-resources/infographics/best-practices-in-viral-vector-analytical-characterization">인포그래픽</a>을 다운로드하여 바이러스 벡터 분석 특성화를 수행하는 팁과 고려할 점에 대해 확인하세요.</h4> </div> </div> </div> </div> <style type="text/css"> #container-1951767544{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1951767544 { border-radius: px; } </style> </div> </div> </div> <style type="text/css"> #container-541002130{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-541002130 { border-radius: px; } </style> </div> </div> </div> </div> </div> </div> </div> </div> </div> <style type="text/css"> #container-2026543050{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-2026543050 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--xsmall--12 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--12"> <div class="cmp-container-inner py-3 viral-vector-services-accordion-container " id="container-1908404600"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-accordion aem-GridColumn aem-GridColumn--default--12"> <div class="accordion" id="technology-transfers"> <div class="accordion-item"> <div class="accordion-header" id="heading-technology-transfers"> <button class="accordion-button 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class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--default--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--offset--small--0 aem-GridColumn--default--6 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner me-lg-3 me-md-0 " id="container-958666785"> <div class="aem-Grid aem-Grid--6 aem-Grid--small--6 aem-Grid--default--6 aem-Grid--xsmall--6 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--xsmall--0 aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--6 aem-GridColumn--small--6"> <div id="text-8797bfbfbd" class="cmp-text list-style-check"> <ul style="color: rgb(38,34,98);"> <br /> <li style="color: rgb(38,34,98);"><b>초기 시설 적합성 평가</b></li> <br /> <li style="color: rgb(38,34,98);"><b>상세한 갭 분석 및 위험 평가</b></li> <br /> <li style="color: rgb(38,34,98);"><b>상세한 공정 설명</b></li> <br /> <li style="color: 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</div> </div> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--default--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--offset--small--0 aem-GridColumn--default--6 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner me-lg-3 me-md-0 " id="container-422567871"> <div class="aem-Grid aem-Grid--6 aem-Grid--small--6 aem-Grid--default--6 aem-Grid--xsmall--6 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--xsmall--0 aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--6 aem-GridColumn--small--6"> <div id="text-d0bfbbc836" class="cmp-text list-style-check"> <ul style="color: rgb(38,34,98);"> <br /> <li style="color: rgb(38,34,98);"><b>CMC 서류 작성</b></li> <br /> <li style="color: rgb(38,34,98);"><b>갭 분석 및 CMC 서류 검토</b></li> <br /> <li style="color: rgb(38,34,98);"><b>CMC 전략 컨설팅</b></li> <br /> <li 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background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1115666232 { border-radius: px; } </style> </div> </div> </div> </div> <style type="text/css"> #well-1879027906 { border-radius: 0px; } </style> </div> <div class="cmp-well aem-GridColumn aem-GridColumn--default--12"> <div class="well " style="background-position-x: center;background-position-y: center;background-image: url('/content/dam/patheon/global/site-images/softgels/Made In Background Blue.png');" id="well-202632774"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-container aem-GridColumn--default--none aem-GridColumn aem-GridColumn--default--12 aem-GridColumn--offset--default--0"> <div class="cmp-container-inner containerOne equalizeHeights h-100" id="container-154496555"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-container aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner py-3 " id="container-1745860701"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="text aem-GridColumn--default--none aem-GridColumn aem-GridColumn--default--11 aem-GridColumn--offset--default--0"> <div id="text-38f8c10011" class="cmp-text list-style-bullets"> <h4 style="text-align: left;"><span style="color: rgb(255,255,255);"><b>개발 위험을 완화하고 빠른 임상으로의 진행을 지원합니다.</b></span></h4> <h4><span style="color: rgb(255,255,255);">Patheon Quick to Clinic™️ viral vector services</span></h4> </div> </div> </div> </div> <style type="text/css"> #container-1745860701{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1745860701 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner py-3 " id="container-955476733"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--xsmall--12 aem-Grid--medium--12 "> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-b66235dfb2" class="cmp-text list-style-check"> <p style="text-align: left;font-size: 18.0px;"><span style="color: rgb(255,255,255);">치료제를 더 빨리 시장에 출시하고, 그 과정에서 복잡성을 줄이고 싶다면 아데노 관련 바이러스(AAV) 및 렌티바이러스(LV) 벡터를 위한 고성능, 확장 가능형 플랫폼인 Patheon Quick to Clinic™️ viral vector services을 활용하세요. 추가 비용 없이 글로벌 규제 제출에 대한 위험을 제거하여 유전자 치료제를 더욱 빠르게 출시할 수 있도록 지원합니다.</span><br /> </p> </div> </div> <div class="cmp-button aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--medium--3 aem-GridColumn--default--none aem-GridColumn--xsmall--3 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--3 aem-GridColumn--offset--default--0"> <div id="button-751019998" class="btn-wrapper"> <a class=" btn btn-style-primary icon-placement-left " 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class="aem-Grid aem-Grid--12 aem-Grid--default--12 aem-Grid--xsmall--12 aem-Grid--medium--12 "> <div class="text aem-GridColumn aem-GridColumn--default--12"> <div id="text-12c455ba77" class="cmp-text list-style-check"> <p style="text-align: left;font-size: 18.0px;"><span style="color: rgb(255,255,255);">독성 연구는 임상시험 전 규제 요건을 충족하고 신약 후보물질의 편익 비율을 평가하는 데 매우 중요합니다. 그러나 고품질의 독성 물질을 확보하는 데 시간이 오래 걸리고, 독성 물질 생상 프로세스와 현행 cGMP 규정 간 비호환성으로 인해 원활한 전환에 어려움을 겪을 수 있습니다. 당사의 Direct-to-toxicology viral vector services는 아데노 연관 바이러스(AAC) 및 렌티바이러스(LV) 생산 공정을 통해 독성 물질을 신속하게 확보하여 6개월 이내에 완료할 수 있도록 지원합니다.</span><br /> </p> </div> </div> <div class="cmp-button aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--medium--3 aem-GridColumn--default--none aem-GridColumn--xsmall--3 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--3 aem-GridColumn--offset--default--0"> <div id="button-1146612138" class="btn-wrapper"> <a class=" btn 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Brammer Bio와 Henogen이 업계에서 쌓아온 지식과 경험은 물론, Fisher Clinical Services의 글로벌 임상 공급망 역량도 적극 활용합니다.</p> </div> </div> </div> </div> <style type="text/css"> #container-759050676{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-759050676 { border-radius: px; } </style> </div> </div> </div> </div> <style type="text/css"> #well-1314804442 { border-radius: 0px; } </style> </div> <div class="cmp-well aem-GridColumn aem-GridColumn--default--12"> <div class="well " style="background-color: #EBF2FA;background-position-x: center;background-position-y: center;border-color: #FFFFFF;" id="well-902515061"> <div class="container-fluid container-lg "> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-container aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner py-3 " id="container-1298890535"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-carousel aem-GridColumn aem-GridColumn--default--12"> <link rel="stylesheet" href="/etc.clientlibs/multisitecommons/clientlibs/vendor/slick_carousel.min.css" type="text/css"> <script src="/etc.clientlibs/multisitecommons/clientlibs/vendor/slick_carousel.min.js"></script> <div class="container-fluid container-md ps-0 pe-0"> <div class="carouselWrapper" data-arrowpos="bottom" data-disableautoplay="true" data-objs="[{ &#34;breakpoint&#34;: 594, &#34;settings&#34;: { &#34;speed&#34;: 2000, &#34;slidesToShow&#34;: 1, &#34;slidesToScroll&#34;: 1, &#34;arrows&#34;: true, &#34;infinite&#34;: true, &#34;dots&#34;: false, &#34;centerMode&#34;: true}}]" data-numslides="1" data-flex="false" id="carousel-1850331238"> <div class="aem-Grid aem-Grid--12 aem-Grid--default--12 "> <div class="cmp-container aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-2027729384"> <div class="aem-Grid aem-Grid--12 aem-Grid--small--12 aem-Grid--default--12 aem-Grid--xsmall--12 aem-Grid--phone--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--12 aem-GridColumn--offset--phone--0 aem-GridColumn--offset--default--0 aem-GridColumn--offset--medium--0 aem-GridColumn--phone--none aem-GridColumn--phone--6 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--default--6"> <div class="cmp-container-inner py-5 " id="container-824988682"> <div class="aem-Grid aem-Grid--6 aem-Grid--small--12 aem-Grid--default--6 aem-Grid--xsmall--6 aem-Grid--phone--6 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--phone--6 aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--xsmall--6 aem-GridColumn--small--12 aem-GridColumn--default--6"> <div id="text-290866e3f1" class="cmp-text list-style-bullets"> <h4><b><a href="https://www.patheon.com/us/en/site-locations/plainville-ma.html">Plainville, Massachusetts, USA</a></b></h4> <h4> </h4> </div> </div> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--phone--none aem-GridColumn--xsmall--newline aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--xsmall--6 aem-GridColumn--small--12 aem-GridColumn--phone--2 aem-GridColumn--offset--phone--1 aem-GridColumn--default--6"> <div id="text-13ef7b3e73" class="cmp-text list-style-bullets"> <p>State-of-the-art Plainville site (290,000 ft<sup>2</sup>) designed for end-to-end viral vector services, from process development to commercial manufacturing, with unparalleled capacity and capabilities to meet market demands.</p> </div> </div> <div class="cmp-container aem-GridColumn--default--none aem-GridColumn--medium--4 aem-GridColumn--xsmall--4 aem-GridColumn aem-GridColumn--phone--4 aem-GridColumn--offset--default--0 aem-GridColumn--default--4 aem-GridColumn--small--4"> <div class="cmp-container-inner py-3 " id="container-296155894"> <div class="aem-Grid aem-Grid--4 aem-Grid--default--4 aem-Grid--xsmall--4 aem-Grid--medium--4 "> <div class="cmp-button aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--medium--3 aem-GridColumn--default--none aem-GridColumn--xsmall--3 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--offset--default--0 aem-GridColumn--default--2"> <div id="button-568160951" class="btn-wrapper"> <a class=" btn btn-style-primary icon-placement-left " href="https://www.patheon.kr/insights-resources/sites/plainville-ma" role="button" target="_self"> Learn more </a> </div> <style> #button-568160951 .btn-style-quickLink { border-left: 6px solid #1E8AE7; 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background-color: ; background-size: cover; background-position: center; min-height: 338px; } #container-1790946773 { border-radius: 6px; } </style> </div> </div> </div> <style type="text/css"> #container-2027729384{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-2027729384 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-1912724840"> <div class="aem-Grid aem-Grid--12 aem-Grid--small--12 aem-Grid--default--12 aem-Grid--xsmall--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--12 aem-GridColumn--offset--default--0 aem-GridColumn--offset--medium--0 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--default--6"> <div class="cmp-container-inner py-5 " id="container-438567078"> <div class="aem-Grid aem-Grid--6 aem-Grid--small--12 aem-Grid--default--6 aem-Grid--xsmall--12 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--6"> <div id="text-acd9374e62" class="cmp-text list-style-bullets"> <h4><b><a href="https://www.patheon.com/us/en/site-locations/seneffe-be.html">Seneffe, Belgium, Europe</a></b></h4> <p><a href="https://www.patheon.com/us/en/site-locations/seneffe-be.html"></a></p><p> </p> <p></p> </div> </div> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--6"> <div id="text-744ab5f4d8" class="cmp-text list-style-bullets"> <p>The Seneffe site (34,000 ft<sup>2</sup>) supports both clinical and commercial manufacturing. This site has over 20 years experience in virus and viral vector manufacturing and has been previously approved by EMA for commercial vaccine production.</p> </div> </div> <div class="cmp-container aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--medium--4 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--xsmall--6 aem-GridColumn--offset--default--0 aem-GridColumn--default--4 aem-GridColumn--small--4"> <div class="cmp-container-inner py-3 " id="container-276524276"> <div class="aem-Grid aem-Grid--4 aem-Grid--default--4 aem-Grid--xsmall--6 aem-Grid--medium--4 "> <div class="cmp-button aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--medium--3 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--xsmall--6 aem-GridColumn--offset--default--0 aem-GridColumn--default--2"> <div id="button-597603423" class="btn-wrapper"> <a class=" btn btn-style-primary icon-placement-left " href="https://www.patheon.kr/insights-resources/sites/seneffe-be" role="button" target="_self"> Download Factsheet </a> </div> <style> #button-597603423 .btn-style-quickLink { border-left: 6px solid #1E8AE7; } #button-597603423 { padding-right:0px; padding-left:0px; } </style> </div> </div> </div> <style type="text/css"> #container-276524276{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-276524276 { border-radius: px; } </style> </div> </div> </div> <style type="text/css"> #container-438567078{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-438567078 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--12 aem-GridColumn--offset--default--0 aem-GridColumn--offset--medium--2 aem-GridColumn--small--8 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--offset--small--2 aem-GridColumn--default--6 aem-GridColumn--medium--8"> <div class="cmp-container-inner ms-lg-3 ms-md-0 " id="container-957349642"> <div class="aem-Grid aem-Grid--6 aem-Grid--small--8 aem-Grid--default--6 aem-Grid--xsmall--12 aem-Grid--medium--8 "> </div> </div> <style type="text/css"> #container-957349642{ background-image: url('/content/dam/patheon/global/library/thumbnails/site-locations/site-be-seneffe.jpg'); background-color: ; background-size: cover; background-position: center; min-height: 338px; } #container-957349642 { border-radius: 6px; } </style> </div> </div> </div> <style type="text/css"> #container-1912724840{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-1912724840 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn aem-GridColumn--default--12"> <div class="cmp-container-inner " id="container-1152574758"> <div class="aem-Grid aem-Grid--12 aem-Grid--small--12 aem-Grid--default--12 aem-Grid--xsmall--12 aem-Grid--medium--12 "> <div class="cmp-container aem-GridColumn--small--none aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--12 aem-GridColumn--offset--default--0 aem-GridColumn--offset--medium--0 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--offset--small--0 aem-GridColumn--default--6"> <div class="cmp-container-inner py-5 " id="container-433493580"> <div class="aem-Grid aem-Grid--6 aem-Grid--small--12 aem-Grid--default--6 aem-Grid--xsmall--12 aem-Grid--medium--12 "> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--default--5 aem-GridColumn--small--5 aem-GridColumn--offset--default--0"> <div id="text-edd8927eb2" class="cmp-text list-style-bullets"> <h4><b><a href="https://www.patheon.com/us/en/site-locations/cambridge-ma.html">Cambridge, Massachusetts, United States</a></b></h4> <p><a href="https://www.patheon.com/us/en/site-locations/cambridge-ma.html"><h4> </h4> </a></p> </div> </div> <div class="text aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--xsmall--12 aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--small--12 aem-GridColumn--default--6"> <div id="text-856057c0b6" class="cmp-text list-style-bullets"> <p>Our Cambridge facility (140,000 square feet) performs process characterization, process validation, late-phase, and commercial manufacturing. This site has been manufacturing viral vectors since 2018 and received its first commercial license in Q1/2021.</p> </div> </div> <div class="cmp-container aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--medium--4 aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--xsmall--7 aem-GridColumn--offset--default--0 aem-GridColumn--default--4 aem-GridColumn--small--4"> <div class="cmp-container-inner py-3 " id="container-1930912575"> <div class="aem-Grid aem-Grid--4 aem-Grid--default--4 aem-Grid--xsmall--7 aem-Grid--medium--4 "> <div class="cmp-button aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--medium--3 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--xsmall--7 aem-GridColumn--offset--default--0 aem-GridColumn--default--2"> <div id="button-711733230" class="btn-wrapper"> <a class=" btn btn-style-primary icon-placement-left " href="https://www.patheon.kr/insights-resources/sites/cambridge-ma" role="button" target="_self"> Download Factsheet </a> </div> <style> #button-711733230 .btn-style-quickLink { border-left: 6px solid #1E8AE7; 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Watch our webinar to learn about our capabilities and approaches for preparing viral vectors for commercialization.</p> </span> <a href="https://www.patheon.com/us/en/insights-resources/webinars/preparing-viral-vector-productions-for-commercialization.html" target="_self" class="btn library-card-btn library-card-primary-btn "> View Webinar </a> </div> </div> </div> </div> </div> <style type="text/css"> #container-25040909{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-25040909 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--medium--newline aem-GridColumn--xsmall--newline aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--offset--default--0"> <div class="cmp-container-inner py-3 " id="container-179983208"> <div class="aem-Grid aem-Grid--0 aem-Grid--default--3 aem-Grid--xsmall--3 aem-Grid--medium--3 "> <div class="cmp-library-card aem-GridColumn--medium--3 aem-GridColumn--default--none aem-GridColumn--xsmall--3 aem-GridColumn aem-GridColumn--default--3 aem-GridColumn--offset--default--0"> <div class="library-card imgType-top" id="library_card-402697783"> <div class="img-and-tag"> <img class="library-card-top-img" src="/content/dam/temp_patheon/library/thumbnails/supply-chain-management/Supply_Chain_ManagementF.png" alt=""/> <div class="upper-right-tag"> <i class="fak fa-patheon-infographic pad-right icon"></i> Infographic </div> </div> <div class="library-card-body"> <p class="library-card-preheader"> Inforgraphic </p> <p class="library-card-title"> Regulatory pathways for CGT and ATMP products </p> <span class="library-card-desc"> <p>CGT is one of the world's fastest-growing therapeutic areas today. Instead of treating patients for the rest of their lives, these therapies offer them hope of a cure. In this infographic, we will review three tips for achieving regulatory success.</p> <p><a href="http://www.patheon.com/us/en/insights-resources/infographics/regulatory-pathways-for-cgt-and-atmp-products.html"> </a></p> </span> <a href="https://www.patheon.com/us/en/insights-resources/infographics/regulatory-pathways-for-cgt-and-atmp-products.html" target="_self" class="btn library-card-btn library-card-primary-btn "> View Infographic </a> </div> </div> </div> </div> </div> <style type="text/css"> #container-179983208{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-179983208 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--medium--newline aem-GridColumn--xsmall--none aem-GridColumn--medium--12 aem-GridColumn aem-GridColumn--offset--default--0"> <div class="cmp-container-inner 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광범위한 기술 및 규제 전문성을 통해, 당사는 고객이 위험을 제거하고 치료제의 시장 진출을 가속화할 수 있도록 지원하기 위해 최선을 다하고 있습니다.</p> <ol> </ol> </span> <a href="https://www.patheon.kr/insights-resources/fact-sheets/viral-vector-development-and-manufacturing-services" target="_self" class="btn library-card-btn library-card-primary-btn "> 더 보기 </a> </div> </div> </div> </div> </div> <style type="text/css"> #container-498729260{ background-image: url(''); background-color: ; background-size: cover; background-position: center; min-height: px; } #container-498729260 { border-radius: px; } </style> </div> <div class="cmp-container aem-GridColumn--offset--medium--0 aem-GridColumn--medium--none aem-GridColumn--offset--xsmall--0 aem-GridColumn--default--none aem-GridColumn--xsmall--none aem-GridColumn aem-GridColumn--default--3 aem-GridColumn--offset--default--0 aem-GridColumn--medium--6"> <div class="cmp-container-inner me-3 " id="container-654678430"> <div class="aem-Grid aem-Grid--3 aem-Grid--default--3 aem-Grid--xsmall--12 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