Manufacturability Assessment and Optimization Services

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With strict regulation and effective execution, we are dedicated to providing the most valuable solutions to complete your projects. </p>  <b class="Highlights_tit">Highlights</b> <ul class="HighlightsArea"> <li class="col-md-6 col-lg-6 col-sm-6"> <img src="static/images/Solutions-menu-lights-pic-1.jpg" srcset="static/images/Solutions-menu-lights-pic-1.webp 1x" width="201" height="131" loading="lazy"><a href="discovery-services.html" class="bannerbutton"><i class="fa fa-angle-right"></i>Discovery Services</a> </li> <li class="col-md-6 col-lg-6 col-sm-6"> <img src="static/images/Solutions-menu-lights-pic-2.jpg" srcset="static/images/Solutions-menu-lights-pic-2.webp 1x" width="201" height="131" loading="lazy"><a href="engineering-services.html" class="bannerbutton"> <i class="fa fa-angle-right"></i>Engineering Services </a> </li> </ul> </li> </ul> </div> </div> </li> <li> <span>Characterization</span> <div class="secondMenu"> <div class="second-menu-area-box"> <ul style="margin-top:0;">  <li class="col-md-8 col-lg-8 col-sm-8"> <ul class="navi-menu-2 MenuList"><li class="navi-menu-li-2 col-md-4 col-lg-4 col-sm-4"><a href="javascript:void(0)" title="Binding Analysis">Binding Analysis</a><ul class="navi-menu-3 three_menu"><li class="navi-menu-li-3"><a href="/Antibody-Affinity-Measurement.html" title="Affinity Measurement">Affinity Measurement</a><ul class="navi-menu-4 three_menu"><li class="navi-menu-li-4"><a href="/Affinity-Measurement-Services-for-Specific-Antibodies.html" title="Antibody Affinity Measurement">Antibody Affinity Measurement</a></li><li class="navi-menu-li-4"><a href="/Membrane-Proteins-Affinity-Measurement.html" title="Membrane Protein Affinity Measurement">Membrane Protein Affinity Measurement</a></li><li class="navi-menu-li-4"><a href="/Affinity-Measurement-Services-for-Small-Molecules.html" title="Small Molecule Affinity Measurement">Small Molecule Affinity Measurement</a></li></ul></li><li class="navi-menu-li-3"><a href="/precision-paratope-mapping-service.htm" title="Paratope Mapping">Paratope Mapping</a></li><li class="navi-menu-li-3"><a href="/Monoclonal-Antibody-Epitope-Binning.html" title="Epitope Binning">Epitope Binning</a></li><li class="navi-menu-li-3"><a href="/cremap.html" title="Epitope Mapping">Epitope Mapping</a><ul class="navi-menu-4 three_menu"><li class="navi-menu-li-4"><a href="/cremap-b-cell-epitope-mapping-service.html" title="B Cell Epitope Mapping">B Cell Epitope Mapping</a></li><li class="navi-menu-li-4"><a href="/cremap-t-cell-epitope-discovery-service.html" title="T Cell Epitope Discovery">T Cell Epitope Discovery</a></li></ul></li><li class="navi-menu-li-3"><a href="/high-throughput-membrane-protein-array-screening-services.html" title="Antibody Off-Target Identification & Specificity Profiling">Antibody Off-Target Identification & Specificity Profiling</a></li></ul></li><li class="navi-menu-li-2 col-md-4 col-lg-4 col-sm-4"><a href="javascript:void(0)" title="Sequence Analysis">Sequence Analysis</a><ul class="navi-menu-3 three_menu"><li class="navi-menu-li-3"><a href="/next-generation-antibody-sequencing.html" title="<i>De Novo</i> Sequencing"><i>De Novo</i> Sequencing</a><ul class="navi-menu-4 three_menu"><li class="navi-menu-li-4"><a href="/De-Novo-Human-Humanized-Antibody-Sequencing-Service.html" title="Human/Humanized Antibody Sequencing">Human/Humanized Antibody Sequencing</a></li><li class="navi-menu-li-4"><a href="/De-Novo-Biosimilar-monoclonal-antibodies-Sequencing-Service.html" title="Biosimilar mAb Sequencing">Biosimilar mAb Sequencing</a></li><li class="navi-menu-li-4"><a href="/de-novo-sdab-sequencing-service.html" title="Single Domain Antibody (SdAb) Sequencing">Single Domain Antibody (SdAb) Sequencing</a></li><li class="navi-menu-li-4"><a href="/De-Novo-Rodent-Antibody-Sequencing-Service.html" title="Rodent Antibody Sequencing">Rodent Antibody Sequencing</a></li><li class="navi-menu-li-4"><a 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href="/in-silico-Immunogenicity-Assessment.html" title="<i>In Silico</i> Assessment"><i>In Silico</i> Assessment</a></li><li class="navi-menu-li-4"><a href="/ex-vivo-Immunogenicity-Assessment.html" title="<i>Ex Vivo</i> Assessment"><i>Ex Vivo</i> Assessment</a></li><li class="navi-menu-li-4"><a href="/in-vivo-Immunogenicity-Assessment.html" title="<i>In Vivo</i> Assessment"><i>In Vivo</i> Assessment</a></li><li class="navi-menu-li-4"><a href="/Anti-drug-Antibodies-ADA-Assays.html" title="Anti-Drug Antibodies (ADA) Assay">Anti-Drug Antibodies (ADA) Assay</a></li></ul></li><li class="navi-menu-li-3"><a href="/Magic-Therapeutic-Antibody-Discovery-Service.htm" title="Repertoire Analysis">Repertoire Analysis</a><ul class="navi-menu-4 three_menu"><li class="navi-menu-li-4"><a href="/magic-bcr-repertoire-analysis.html" title="BCR Repertoire Analysis">BCR Repertoire Analysis</a></li><li class="navi-menu-li-4"><a href="/magic-tcr-repertoire-sequencing-service.html" title="TCR Repertoire 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Pilot studies conducted by our labs have suggested that these results can effectively guide the customer to the most appropriate candidate for process development. Meanwhile, we have also developed a variety of assays to improve the developability condition of potential drugs or protein therapeutics. </p> <h2 class="h2_tit page_tab_margin" id="tab1"> Introduction to Manufacturability Assessment and Optimization </h2> <p> Peptides, antibodies, or proteins have shown promising results in treating many kinds of diseases, but side effects still happen and are usually related to the physicochemical property of testing candidates. The safety and efficacy of candidate drugs still need to be analyzed by “manufacturability”. Manufacturability assessment and optimization play an important role in detecting the suitability of a therapeutic molecule. As a result, recent studies have revealed that high-throughput methods should be a powerful tool for eliminating the instabilities, toxicity in successful manufacturability projects. In general, comprehensive assessment and optimization are based on computational and experimental analysis strategies. <em>In silico</em> prediction, technologies have been widely used for modifying the structure and sequences of screened molecules to improve their stability and manufacturability in clinical use. In addition, the application of experimental approaches is an emerging area, and much progress has been made to detect the solution properties, chemical stability at different concentrations. </p> <p class="ServiceShowPic"> <img src="static/img/Manufacturability-Assessment-and-Optimization-1.jpg" width="700" alt="Manufacturability Assessment and Optimization Platform." /> Fig.1 Manufacturability Assessment and Optimization Platform. </p> <h2 class="h2_tit page_tab_margin" id="tab2"> <a href="virtual-prediction-of-manufacturability-assessment-and-improvement.html">Virtual Prediction of Manufacturability Assessment and Improvement</a> </h2> <p> As an expert in manufacturability assessment, Creative Biolabs has generated a novel <em>in silico</em> analysis platform to provide a series of services to measure multiple manufacturability parameters in diverse target molecules. This platform can rapidly evaluate physical and chemical parameters, including viscosity, solubility, critical residues, aggregation, immunogenicity as well as degradation/ PTMs, in a cost-effective manner. Furthermore, we also offer a suite of predictive models for engineering the structure of protein therapeutic candidates to improve the evaluation results of manufacturability. For instance, The aggregation and stability risks of monoclonal antibodies against CD19 have been assessed by our <em>in silico</em> tools. </p> <h2 class="h2_tit page_tab_margin" id="tab3"> <a href="experimental-manufacturability-assessment-and-optimization.html">Experimental Manufacturability Assessment and Optimization</a> </h2> <p> In recent years, Creative Biolabs has designed a novel experimental platform to screen and optimize the manufacturability of test materials in drug research. Up to now, we have successfully accomplished a wide collection of early assessment strategies that can be used to analyze physicochemical stability parameters, deamidation, aggregation propensity, oxidation propensity, as well as solution properties. Subsequent screens and assays are focused on binding specificity and affinity specificity. A number of high-throughput (HT) technologies, such as fluorescence spectroscopy, Nuclear magnetic resonance (NMR), high-performance liquid chromatography (HPLC), dynamic light scattering (DLS), have been proved its applicability in the screening cascade. Additionally, our customize manufacturability optimization services are designed to provide meaningful data for designing better candidates in drug discovery. </p> <p> <strong>Creative Biolabs</strong> offers a manufacturability assessment and optimization platform that is critical to improving the quality, safety, and manufacturability of potential biotherapeutic and drug candidates. If you are interested in our service, please feel free to <a href="#OnlineInquiry">contact us</a>. </p><br> <p class="pronote"><i class="fa fa-exclamation-triangle"></i>All listed services and products are For Research Use Only. Do Not use in any diagnostic or therapeutic applications.</p> <div class="related-sections"> <b>Related Sections</b> <b>Services</b> <ul class="related-sections-ul"> <li><a href="/drug-discovery/therapeutics/preliminary-screening-of-drug-candidates.htm" >Preliminary Screening of Drug Candidates</a></li> <li><a href="/drug-discovery/therapeutics/immunogenicity-assessment-of-drug-candidates.htm" >Immunogenicity Assessment of Drug Candidates</a></li> <li><a href="/drug-discovery/therapeutics/in-vivo-fitness-assessment-of-drug-candidates.htm" ><em> In Vivo</em> Fitness Assessment of Drug Candidates</a></li> </ul> </div> </div> <div class="col-md-3"> <a name="OnlineInquiry"></a> <div class="rightcontact inquiry_bg_small"> <div class="rig_tit">Online Inquiry</div> <link rel="preconnect" href="https://www.recaptcha.net" /> <style type="text/css">.grecaptcha-badge { opacity: 0; }</style> <script 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