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Biosimilar Development Services // 3P Biopharmaceuticals.

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and Services</a></li> </ul></div> </div> </ul> </div> <div class="navigation-button col-span-12 md:col-span-2 self-start"> <button class="appearance-none w-full font-medium uppercase flex items-center justify-between focus:outline-none py-4 px-12 md:px-3 lg:px-5 " data-toggle-button data-duration="400"> Commercial <span class="w-1.5 transform fill-pink -rotate-90 block ml-4"> <svg class="fill-inherit w-full h-full" vxmlns="http://www.w3.org/2000/svg" viewBox="0 0 114.32 200"> <polygon points="100,200 0,100 100,0 114.32,14.31 28.62,100 114.32,185.69 "/> </svg> </span> </button> <ul class="hidden normal-case transform transition-all list-none" data-toggle-reveal> <div class="px-12 md:px-6 lg:w-11/12 dropdown-menu "> <div class="menu-mammalian-commercial-container"><ul class="list-none mb-0 p-0" role="menubar"><li id="menu-item-1624" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-1624"><a 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cGMP guidelines.</h3> <h3>3P biosimilar development services</h3> <h5>Analytical methods</h5> <p>Analytical methods are developed according to their intended purpose (identity, impurity, assay or other) in supporting IPC, release and/or stability testing. Analytics are designed based on the principles defined in ICH Q6B guidelines, with qualification activities following ICH Q2 guidelines.</p> <h5>Quality Target Product Profile (qTPP)</h5> <p>We use the Quality Target Product Profile (qTPP) step to evaluate how the innovator varies from batch to batch while identifying Critical Quality Attributes (CQA). Data generated during this evaluation is used throughout the biosimilar development activities. Once the quality attributes and variability of the innovator molecules are known, analytical testing can be defined.</p> <h5>Process development</h5> <p>During process development, we test biological activity, purity, and other relevant quality attributes to assure the quality of the candidate. Demonstration batches are performed to show process robustness and generate protein used for reference material preparation, formulation, and initial stability studies.</p> <h5>Formulation studies</h5> <p>The formulation of the biosimilar does not necessarily have to be the same as the originator molecule. However, the guidelines recommend justifying any differences in excipients or composition. Therefore, we aim to formulate the biosimilar using the same composition as the originator molecule to avoid this complexity while seeking to prevent any potential impact on product stability or clinical results. Formulation studies are carried out under the EMA CHMP/QWP/396951/2006 guidelines and will use excipients (and/or other reagents) described in the relevant Pharmacopoeia.</p> <h3>What we will deliver</h3> <p>We deliver a fully managed biosimilar development service, ensuring that traceability and comparability are demonstrated throughout all development stages.</p> <h4>Our dedicated team of specialists will be happy to discuss any of your Biosimilar Development needs. <a title="Let's Share Purpose - Get in touch today" href="/contact/" target="_blank" rel="noopener noreferrer">Contact us</a> on <a href="tel:+34948346480">+34 948 346 480</a> or email <a title="Our dedicated team of specialists will be happy to discuss any of your Development needs" href="mailto:withinus@3pbio.com">withinus@3pbio.com</a></h4> </div> <div class="sidebar lg:w-4/12 lg:px-10 space-y-10 pt-10 lg:pt-0"> <div class="lg:text-mobilebase"> <div class="menu-mammalian-biosimilar-container"><ul class="list-none mb-0 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Biosimilar Development </a> </li> <li class="relative pl-0 pb-1 block" role="none"> <a title="Comparability Studies" href="/services/mammalian-systems/mammalian-comparability-studies/?stage=Mammalian-Biosimilar" role="menuitem" tabindex="0" role="menuitem" class="font-normal text-pink hover:text-navy focus:text-navy no_underline" alt="Comparability Studies"> Comparability Studies </a> </li> <li class="relative pl-0 pb-1 block" role="none"> <a title="Analytical Methods Qualification and Validation" href="/services/mammalian-systems/mammalian-analytical-methods-qualification-and-validation/?stage=Mammalian-Biosimilar" role="menuitem" tabindex="0" role="menuitem" class="font-normal text-pink hover:text-navy focus:text-navy no_underline" alt="Analytical Methods Qualification and Validation"> Analytical Methods Qualification and Validation </a> </li> <li class="relative pl-0 pb-1 block" role="none"> <a title="Viral Clearance Studies &amp; Validation" 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