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property="name">Biopharma Asia</span></a><meta property="position" content="1"></span> > <span property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" title="Go to Magazine Article." href="https://biopharma-asia.com/magazine-articles/" class="archive post-mag_article-archive"><span property="name">Magazine Article</span></a><meta property="position" content="2"></span> > <span property="itemListElement" typeof="ListItem"><a property="item" typeof="WebPage" title="Go to Platform Purification of Six Biosimilar Molecules using Amsphere A3 – Protein A Resin." href="https://biopharma-asia.com/magazine-articles/platform-purification-of-six-biosimilar-molecules-using-amsphere-a3-protein-a-resin-2/" class="post post-mag_article current-item"><span property="name">Platform Purification of Six Biosimilar Molecules using Amsphere A3 – Protein A Resin</span></a><meta property="position" content="3"></span> </div> </div> </div> </div> <section class="main-content"> <div class="container"> <div class="row"> <div class="col-sm-12"> <div class="row"> <div class="col-md-9"> <div id="hero"> <div class="gallery-item"> <a href="https://cytiva.link/zfht6" target="_blank" class="ad-main-slider-1"> <img src="https://biopharma-asia.com/wp-content/uploads/2024/10/4069_CYTIVA-Palltronic-website-Banner-940X300PX_V1.png" class="img-responsive"> </a> </div> </div> <h1 class="bold">Platform Purification of Six Biosimilar Molecules using Amsphere A3 – Protein A Resin</h1> <div class="blog-post-date"> <p> <em>Posted on November 8, 2024  <br> <p>JSR Life Sciences</p> </em> </p> </div> <p><a href="https://biopharma-asia.com/wp-content/uploads/2024/03/jsramps.jpg"><img fetchpriority="high" decoding="async" class="alignnone size-full wp-image-26277" src="https://biopharma-asia.com/wp-content/uploads/2024/03/jsramps.jpg" alt="" width="400" height="208" srcset="https://biopharma-asia.com/wp-content/uploads/2024/03/jsramps.jpg 400w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsramps-300x156.jpg 300w" sizes="(max-width: 400px) 100vw, 400px" /></a></p> <p><a href="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrbox.jpg"><img loading="lazy" decoding="async" class="alignnone size-full wp-image-26278" src="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrbox.jpg" alt="" width="400" height="459" srcset="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrbox.jpg 400w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsrbox-261x300.jpg 261w" sizes="(max-width: 400px) 100vw, 400px" /></a></p> <p>Currently more than 70 biosimilar mAbs (monoclonal antibodies) are under development and multiple originator mAbs are going off-patent in the next 3-4 years. Protein A resin remains the most important workhorse for the purification of monoclonal antibodies. Protein A resin has a high impact on both development and manufacturing cost, in particular during early stage clinical phases. This application note summarizes the key performance parameters for our high capacity protein A resin, Amsphere A3, for 6 biosimilar molecules of which five are mAbs and one is a Fc-fusion protein.</p> <p><strong>Materials and Methods<br /> </strong>TABLE 1: MONOCLONAL ANTIBODIES AND FUSION PROTEIN—ALL BIOSIMILARS DERIVED FROM CHO CELL LINE CLARIFIED BY CENTRIFUGATION AND 0.22 MICROMETER FILTRATION<strong><br /> </strong></p> <p><a href="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt1.jpg"><img loading="lazy" decoding="async" class="alignnone size-full wp-image-26279" src="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt1.jpg" alt="" width="400" height="135" srcset="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt1.jpg 400w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt1-300x101.jpg 300w" sizes="(max-width: 400px) 100vw, 400px" /></a></p> <p>FIGURE 1: TEST CONDITIONS OF CHROMATOGRAPHY PROCESS</p> <p><a href="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf1.jpg"><img loading="lazy" decoding="async" class="alignnone size-full wp-image-26280" src="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf1.jpg" alt="" width="400" height="298" srcset="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf1.jpg 400w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf1-300x224.jpg 300w" sizes="(max-width: 400px) 100vw, 400px" /></a></p> <p>TABLE 2: EXPERIMENTAL METHODS AND MATERIALS</p> <p><a href="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt2.jpg"><img loading="lazy" decoding="async" class="alignnone size-full wp-image-26281" src="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt2.jpg" alt="" width="400" height="150" srcset="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt2.jpg 400w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt2-300x113.jpg 300w" sizes="(max-width: 400px) 100vw, 400px" /></a></p> <p><strong>Results</strong><br /> FIGURE 2: PLATFORM PURIFICATION OF FIVE BIOSIMILAR ANTIBODIES USING AMSPHERE A3</p> <p><a href="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf2.jpg"><img loading="lazy" decoding="async" class="alignnone size-full wp-image-26282" src="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf2.jpg" alt="" width="800" height="215" srcset="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf2.jpg 800w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf2-300x81.jpg 300w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf2-768x206.jpg 768w" sizes="(max-width: 800px) 100vw, 800px" /></a></p> <p>TABLE 3: HCP REMOVAL</p> <p><a href="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt3.jpg"><img loading="lazy" decoding="async" class="alignnone size-full wp-image-26283" src="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt3.jpg" alt="" width="800" height="215" srcset="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt3.jpg 800w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt3-300x81.jpg 300w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsrt3-768x206.jpg 768w" sizes="(max-width: 800px) 100vw, 800px" /></a></p> <p>FIGURE 3: LEACHED PROTEIN A</p> <p><a href="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf3.jpg"><img loading="lazy" decoding="async" class="alignnone size-full wp-image-26284" src="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf3.jpg" alt="" width="800" height="214" srcset="https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf3.jpg 800w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf3-300x80.jpg 300w, https://biopharma-asia.com/wp-content/uploads/2024/03/jsrf3-768x205.jpg 768w" sizes="(max-width: 800px) 100vw, 800px" /></a></p> <p><strong>Discussion and Conclusions</strong><br /> Amsphere A3 consistently delivers high binding capacities and excellent impurity clearance for multiple biosimilar molecules as highlighted in this application note. Amsphere A3 excels with comparably high DBC demonstrating its potential to improve the process economics for biosimilar development and manufacturing. In addition, the data underlines the suitability of Amsphere A3 as a platform, since the same protocol was used for all investigated mAbs, consistently yielding excellent performance results with standard wash and elution buffers.</p> <p>AmsphereTM is a global trademark of JSR Corporation©2016-2017 JSR Corporation – All rights reserved.<br /> For more information visit <a href="http://www.jsrlifesciences.com">www.jsrlifesciences.com</a></p> <hr> <div class='apss-social-share apss-theme-1 clearfix '> <div class='apss-facebook apss-single-icon'> <a rel='nofollow' title="Share on Facebook" target='_blank' href='https://www.facebook.com/sharer/sharer.php?u=https://biopharma-asia.com/magazine-articles/platform-purification-of-six-biosimilar-molecules-using-amsphere-a3-protein-a-resin-2/'> <div class='apss-icon-block clearfix'> <i class='fab fa-facebook-f'></i> <span class='apss-social-text'>Share on Facebook</span> <span class='apss-share'>Share</span> </div> </a> </div> <div class='apss-twitter apss-single-icon'> <a rel='nofollow' href="https://twitter.com/intent/tweet?text=Platform%20Purification%20of%20Six%20Biosimilar%20Molecules%20using%20Amsphere%20A3%20%E2%80%93%20Protein%20A%20Resin&url=https://biopharma-asia.com/magazine-articles/platform-purification-of-six-biosimilar-molecules-using-amsphere-a3-protein-a-resin-2/&" title='Share on Twitter' target='_blank'> <div class='apss-icon-block clearfix'> <i class='fab fa-twitter'></i> <span class='apss-social-text'>Share on Twitter</span><span class='apss-share'>Tweet</span> </div> </a> </div> <div class='apss-linkedin apss-single-icon'> <a rel='nofollow' title='Share on LinkedIn' target='_blank' href='http://www.linkedin.com/sharing/share-offsite/?url=https://biopharma-asia.com/magazine-articles/platform-purification-of-six-biosimilar-molecules-using-amsphere-a3-protein-a-resin-2/'> <div class='apss-icon-block clearfix'><i class='fab fa-linkedin'></i> <span class='apss-social-text'>Share on LinkedIn</span> <span class='apss-share'>Share</span> </div> </a> </div> </div> <hr> <div class="row"> <div class="col-md-12"> </div> </div> <div id="signup-form"> <h3><strong>Subscribe to our FREE newsletter and WEBINAR UPDATES</strong></h3> <p class="red"><strong>We will not sell or give your information to a third party. 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