Mammalian Technology Transfer // 3P Biopharmaceuticals.

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clinical manufacturing through to commercial manufacture requires a reliable and scalable process.</h3> <p>A thorough transfer of knowledge, product, and process-related information from our development team to the GMP manufacturing group is crucial to the project’s success in forming the baseline for all further process scale-up and non-GMP batch activities.</p> <h3>3P’s Tech transfer/ scale-up and non-GMP manufacturing services</h3> <p>We prepare documentation to establish upstream and downstream unit operations during the project’s development stage, which is refined further during the scale-up activities and non-GMP batches. Typically, we perform one engineering run to evaluate and confirm that the process is robust and under control. Material generated during the engineering batch can be used as a reference standard and/or for stability studies. We recommend that the product obtained is used for formulation screening and placed on stability testing to understand the product’s shelf-life and its behaviour under different storage conditions (accelerated and stress conditions).</p> <h3>What 3P will deliver?</h3> <p>We will produce transfer and scale-up reports, master batch records and sampling plans. In addition, we provide non-GMP material if available for use in other research studies.</p> <h4>Our dedicated team of specialists will be happy to discuss any of your Mammalian Technology Transfer & Scale-Up 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 Tech Transfer/Scale-Up /ER/Non-GMP Run 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-pre-clinical-container"><ul class="list-none mb-0 p-0" role="menubar"> <li class="relative pl-0 pb-1 block" role="none"> <a title="Cell Line Development" href="/services/mammalian-systems/mammalian-cell-line-development/?stage=Mammalian-Pre-Clinical" role="menuitem" 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