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target="_blank">Mexico</a></li> </ul> </div> </div> </div> </article> <div class="mobileAllMenu"> <button type="button" class="iconMobileAllMenu"><span class="blind">full menu</span></button> </div> </section> </header> <div class="cpnt_breadcrumb"> <ol> <li> <a href="/en-us">HOME</a> </li> <li> <button type="button">BUSINESS</button> <ul> <li> <a href="/en-us/company">ABOUT US</a> </li> <li> <a href="/en-us/business">BUSINESS</a> </li> <li> <a href="/en-us/products">PRODUCTS</a> </li> <li> <a href="/en-us/esg">ESG</a> </li> <li> <a href="/en-us/investment">IR</a> </li> <li> <a href="/en-us/careers">CAREERS</a> </li> </ul> </li> <li> <button type="button">Production</button> <ul> <li> <a href="/en-us/business/overview">Business Areas</a> </li> <li> <a href="/en-us/business/rnd">R&amp;D</a> </li> <li> <a href="/en-us/business/production">Production</a> </li> <li> <a href="/en-us/business/distribution">Distribution</a> </li> </ul> </li> <li> <button type="button">Production Facilities</button> <ul> <li> <a href="/en-us/business/production/facilities">Production Facilities</a> </li> <li> <a href="/en-us/business/production/quality-controls">Quality Management</a> </li> <li> <a href="/en-us/business/production/cmo-cdmo">CDMO</a> </li> </ul> </li> </ol> </div> <main id="wrapper"> <section class="business pl"> <article class="innerContentsWrap "> <div class="contentsWrap"> <div class="contentsHead"> <h2>Production</h2> </div> <div class="contentsBody"> <div class="tabNavWrap type_01" data-aos="fade-up" data-aos-easing="ease" data-aos-duration="500" data-aos-once="true" data-aos-offset="300"> <ul class="tabNavList"> <li class="active"> <a href="/en-us/business/production/facilities" title="Production Facilities">Production Facilities</a> </li> <li> <a href="/en-us/business/production/quality-controls" title="Quality Management">Quality Management</a> </li> <li> <a href="/en-us/business/production/cmo-cdmo" title="CDMO">CDMO</a> </li> </ul> </div> </div> </div> </article> <article class="innerVisualWrap roundMotion"> <img src="/front/assets/common/images/business/img_pl_keyvisual.png" alt="영문"> <img src="/front/assets/common/images/business/img_pl_mkeyvisual.png" alt="영문"> </article> <article class="innerContentsWrap"> <div class="contentsWrap"> <div class="contentsBody mobileMotion"> <div class="topDesc"> <h3> Biopharmaceutical Production Facilities </h3> <p> Celltrion has a production capacity of 250,000L capable of manufacturing everything from drug substances to drug products. We have acquired US FDA and Europe EMA cGMP certifications on all facilities after being the first in Asia to operate FDA cGMP certified animal cell culture facilities. </p> </div> <ul class="descCol intervalTop" data-aos="fade-up" data-aos-easing="ease" data-aos-duration="500" data-aos-once="true" data-aos-offset="300" data-aos-delay="300"> <li class="descItem"> <div class="descImg"> <img src="/front/assets/common/images/business/img_pl_img01.png" alt=""> </div> <div class="descContent"> <strong class="desTit">Plant 1</strong> <div class="desPoint"> <span>100,000L</span> <span class="desSub">12,500L x 8 lines</span> </div> </div> </li> <li class="descItem"> <div class="descImg"> <img src="/front/assets/common/images/business/img_pl_img02.png" alt=""> </div> <div class="descContent"> <strong class="desTit">Plant 2</strong> <div class="desPoint"> <span>90,000L</span> <span class="desSub">15,000L x 6 lines</span> </div> </div> </li> <li class="descItem"> <div class="descImg"> <img src="/front/assets/common/images/business/img_pl_img03.png" alt=""> </div> <div class="descContent"> <strong class="desTit">Plant 3</strong> <div class="desPoint"> <span>60,000L</span> <span class="desSub">7,500L x 8 lines</span> </div> </div> </li> </ul> <div class="topDesc section_sub pit1" data-aos="fade-up" data-aos-easing="ease" data-aos-duration="500" data-aos-once="true" data-aos-offset="300" data-aos-delay="300"> <h3> Small Molecules Production Facilities </h3> <p> Celltrion Pharm's Cheongju Plant, a small molecule pharmaceutical development and production base for Celltrion, provides solutions for all aspects of the production and distribution of tablet and capsule formulations. It also has an FDA cGMP-certified Prefilled Syringe (PFS) production facility with a filling capacity of up to 18 million syringes per year. <a href="https://www.celltrionph.com/en-us/home/index" target="_blank" class="btn_glink_line" title="Go to Celltrion Pharm">Go to Celltrion Pharm</a> </p> </div> </div> </div> </article> <article class="innerContentsWrap t-fullmargin art_product"> <div class="contentsWrap"> <div class="contentsBody mobileMotion"> <div class="product-box"> <h3>Biopharmaceutical Production Process</h3> <div class="list-wrap"> <p class="subTxt">Biopharmaceutical production process consists of cell culture process, purification process and fill and finish process.</p> <button type="button" class="btnMedium btn_en btnSolid"><span>View All</span></button> <ul class="product-list"> <li class="item acitve"> <div class="item-head"> <span class="num">Step. 01</span> <strong class="tit">Cell Culture Process</strong> <div class="drop-btn"> <button type="button"></button> </div> </div> <div class="item-content"> <div class="content-desc"> <strong>1. Preparation of cell culture media and buffer solution</strong> <p> Cell culture media are nutrients essential for cell proliferation. At Celltrion, optimized media for the types and characteristics of cell lines are used and the composition and formulation ratios differ depending on the characteristics, culture method and environment. Media are as important as culture method and environment as they affect the protein productivity and quality. Buffer is a solution that is used to stabilize pH and conductivity to stably extract and purify proteins. It is one of the key factors of purification process because any changes in conditions can affect yield and product quality. </p> <strong>2. Cell culture</strong> <p> When cell line thawing and small-scale flask cell cultures are finished, they are gradually transferred to larger seed bioreactors as they divide and proliferate. Ultimately, cell lines produce antibodies that become raw materials for pharmaceuticals in commercial bioreactors under conditions optimized for productivity and quality. </p> </div> <div class="content-img"><img src="/front/assets/common/images/business/img_bio_01.png" alt=""></div> </div> </li> <li class="item"> <div class="item-head"> <span class="num">Step. 02</span> <strong class="tit">Purification Process</strong> <div class="drop-btn"> <button type="button"></button> </div> </div> <div class="item-content"> <div class="content-desc"> <strong>1. Initial purification</strong> <p> The initial purification process is to purify target proteins from the cell culture fluid harvested during the cell culture process. During this process, target proteins are recovered with high purity and yield through several steps of chromatography and removes viruses through virus inactivation and virus filtration. </p> <strong>2. Final purification</strong> <p> Final purification is the process of adjusting antibody protein concentration to a level suitable for drug substance, exchanging buffers for final formulation and filtering for the last time. </p> <strong>3. Final filtration</strong> <p> As the last step of drug substance production, final filtration is conducted to remove bacteria which leaves injectable buffer and high purity target proteins. </p> </div> <div class="content-img"><img src="/front/assets/common/images/business/img_bio_02.png" alt=""></div> </div> </li> <li class="item"> <div class="item-head"> <span class="num">Step. 03</span> <strong class="tit">Fill and Finish Process</strong> <div class="drop-btn"> <button type="button"></button> </div> </div> <div class="item-content"> <div class="content-desc"> <strong>1. Drug product filling and packaging</strong> <p> The goal of fill and finish process is filling and packaging target proteins into administrable forms. Therefore, it is operated in a thoroughly controlled “clean rooms”. Celltrion received the first-ever GMP approval from the FDA in the field of production of injectable products in Korea and operates the facilities within the FDA and EMA's GMP guidance. </p> </div> <div class="content-img"><img src="/front/assets/common/images/business/img_bio_03.png" alt=""></div> </div> </li> </ul> </div> </div> </div> </div> </article> <article class="innerContentsWrap marginclear"> <div class="contentsWrap"> <div class="contentsBody mobileMotion"> <div class="videoWrap intervalTop section_sub" data-aos="fade-up" data-aos-easing="ease" data-aos-duration="500" data-aos-once="true" data-aos-offset="300"> <div class="video"> <iframe title="vimeo-player" src="https://player.vimeo.com/video/836385599?h=37f19489bb" width="640" height="360" frameborder="0" allowfullscreen></iframe> </div> </div> <div class="leadMoreWrap intervalTop"> <h4>Read More</h4> <ul class="pageList"> <li> <a href="/en-us/business/production/cmo-cdmo" title="CDMO"><span>CDMO</span></a> <img src="/front/assets/common/images/business/img_cc_more.png" alt=""> </li> <li> <a href="/en-us/business/production/quality-controls" title="Quality Management"><span>Quality Management</span></a> <img src="/front/assets/common/images/business/img_qc_more.png" alt=""> </li> </ul> </div> </div> </div> </article> </section> </main> <footer id="footer"> <section class="innerWrap"> <div class="footerTopBtn"> <button type="button" class="iconGoToTop" title="Top scroll"><span class="blind">Top button</span></button> </div> <article id="footerWrap"> <ul class="menu"> <li> <dl> <dt> <a href="javascript:void(0);" title="ABOUT US">ABOUT US</a> </dt> <dd> <a href="/en-us/company/celltrion" title="About Celltrion">About Celltrion</a> </dd> <dd> <a href="/en-us/company/notice" title="Notice">Notice</a> </dd> <dd> <a href="/en-us/company/media-center" title="Media Center">Media Center</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="BUSINESS">BUSINESS</a> </dt> <dd> <a href="/en-us/business/overview" title="Business Areas">Business Areas</a> </dd> <dd> <a href="/en-us/business/rnd" title="R&amp;D">R&amp;D</a> </dd> <dd> <a href="/en-us/business/production" title="Production">Production</a> </dd> <dd> <a href="/en-us/business/distribution" title="Distribution">Distribution</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="PRODUCTS">PRODUCTS</a> </dt> <dd> <a href="/en-us/products/approved" title="Products">Products</a> </dd> <dd> <a href="/en-us/products/pipelines" title="Pipeline">Pipeline</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="ESG">ESG</a> </dt> <dd> <a href="/en-us/esg/environment" title="Environmental">Environmental</a> </dd> <dd> <a href="/en-us/esg/society" title="Social">Social</a> </dd> <dd> <a href="/en-us/esg/governance" title="Governance">Governance</a> </dd> <dd> <a href="/en-us/esg/data-room" title="ESG Archive">ESG Archive</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="IR">IR</a> </dt> <dd> <a href="/en-us/investment/financial" title="Financial Information">Financial Information</a> </dd> <dd> <a href="/en-us/investment/stock-info" title="Stock Summary">Stock Summary</a> </dd> <dd> <a href="/en-us/investment/notice" title="Public Disclosures">Public Disclosures</a> </dd> <dd> <a href="/en-us/investment/ir" title="IR Archive">IR Archive</a> </dd> </dl> </li> <li> <dl> <dt> <a href="javascript:void(0);" title="CAREERS">CAREERS</a> </dt> <dd> <a href="/en-us/careers/talent" title="Our Values">Our Values</a> </dd> <dd> <a href="/en-us/careers/recruit" title="How to Apply">How to Apply</a> </dd> <dd class="outlink"> <a href="https://recruit.celltrion.com/CELLTRION.html" title="Jobs" target="_blank">Jobs</a> </dd> </dl> </li> </ul> <div class="familySite"> <div class="inputSelect dark"> <select id="familySiteSelector" class="selector"> <option>Family Site</option> <option value="https://www.celltrionph.com/en-us/home/index">Celltrion Pharm</option> <option value="https://www.celltrionbeauty.com">Celltrion Skincure</option> <option value="https://www.celltrionwelfare.com">Celltrion Welfare</option> <option value="https://celltrionenter.com">Celltrion Ent.</option> </select> </div> </div> <div class="logo"><span class="blind">Celltrion</span></div> <ul class="sideMenu"> <li><a href="/en-us/terms/privacy-policy" title="Privacy Policy">Privacy Policy</a></li> <li><a href="/en-us/terms/legal-notice" title="Legal Notice">Legal Notice</a></li> <li><a href="/en-us/terms/import-export-policy" title="Export and Import Management Policy">Export and Import Management Policy</a></li> <li><a href="/en-us/contact/inquiry" title="Contact Us">Contact Us</a></li> <li><a href="/en-us/contact/directions" title="Directions">Directions</a></li> </ul> <address>23, Academy-ro, Yeonsu-gu, Incheon, Republic of Korea<span>+82-32-850-5000</span><p>&copy; CELLTRION INC. 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