BioPharm International - November 2022

BioPharm International - November 2022

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30 BioPharm International ® Manufacturing and Facilities 2022 eBook B iopharmaceuticals are revolutionizing the way the industry prevents and treats a broad spectrum of diseases. Therapeutic recombi- nant proteins, including monoclonal anti- bodies (mAbs), bispecifics, and biosimilar molecules, are among the most common biologics developed for therapeutic applications (1). Although versatile and powerful, the living organisms required for the pro- duction of therapeutic proteins can be more difficult to control and optimize in a manufacturing setting than chemical compounds. First, a lead candidate is identified, and, once this happens, an appropriate production cell line is de- veloped before upstream and downstream processes are established and optimized. Although under con- stant pressure, it is critical that biotherapeutic de- velopers spend time and resources getting the cell line development process right. Without a robust production cell line that yields sufficient titers of a high-quality product, the facility will eventually reach a point where scalabilit y becomes limiting, and commercialization is untenable. Cell line de- velopment also offers the opportunity to perform a number of physicochemical analyses and functional assays directly on the therapeutic protein, which will help improve the chances of clinical- and com- mercial-phase success. Since cell line development is such a critical part of the drug development process, biomanufactur- ers should leverage a wide range of solutions to fill the gaps in their interna l capacities and capabil- ities. It is possible to reap new benefits by partner- ing with experienced cell-line development vendors using optimized protein expression platforms that include the host Chinese hamster ovary (CHO) pro- duction cell line, optimized gene expression vectors, cell culture medium, and feed formulations. How- ever, manufacturers may not realize the extent of their options when it comes to developing clonal pro- duction cell lines. This article discusses key factors Exploring Options for Optimizing Cell Line Development Jason Martin is regional product manager of Cell Line, Media & Testing Solutions at Sartorius. Biopharmaceutical manufacturers must consider a surprisingly wide range of factors when deciding where to turn for assistance with cell line development. GIOVANNI CANCEMI - STOCK.ADOBE.COM

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