[{"date_updated":"2026-04-29T11:16:34Z","publication":"Reference Module in Life Sciences","_id":"13712","type":"book_chapter","publisher":"Elsevier","abstract":[{"lang":"eng","text":"Biopharmaceutical quality in upstream mammalian cell culture has historically relied on Quality-by-Test (QbT) paradigm, where fixed processes are verified by end-point assays despite limited process observability and substantial biological variability. This chapter discusses how Process Analytical Technology (PAT), aligned with the Quality-by-Design (QbD) framework, enables measurement-driven process understanding and timely control by linking the trajectories of critical process parameters (CPPs) to critical quality attributes (CQAs). We review fit-for-purpose at-line, on-line, and in-line analytical technologies used in mammalian cell culture and summarize their roles across the process development and manufacturing lifecycle. Applications include multivariate process characterization, state-based monitoring and control, and trajectory-based process supervision. Finally, we outline future directions toward IIoT-enabled connectivity, soft sensors, and integrated multi-sensor PAT platforms, which are expected to support adaptive control strategies, digital twins, and ultimately autonomous biomanufacturing."}],"publication_identifier":{"eisbn":["978-0-12-809633-8"]},"citation":{"mla":"Park, Cheol-Hwan, et al. “Process Analytical Technology in Upstream Mammalian Cell Cultures.” <i>Reference Module in Life Sciences</i>, edited by Bernard D.  Roitberg, Elsevier, 2026, <a href=\"https://doi.org/10.1016/b978-0-443-24738-5.00086-0\">https://doi.org/10.1016/b978-0-443-24738-5.00086-0</a>.","din1505-2-1":"<span style=\"font-variant:small-caps;\">Park, Cheol-Hwan</span> ; <span style=\"font-variant:small-caps;\">Jeon, Yunjoo</span> ; <span style=\"font-variant:small-caps;\">Uhlendorff, Selina</span> ; <span style=\"font-variant:small-caps;\">Pein-Hackelbusch, Miriam</span> ; <span style=\"font-variant:small-caps;\">Lee, Dong-Yup</span>: Process Analytical Technology in Upstream Mammalian Cell Cultures. In: <span style=\"font-variant:small-caps;\">Roitberg, B. D.</span> (Hrsg.): <i>Reference Module in Life Sciences</i>. [Erscheinungsort nicht ermittelbar] : Elsevier, 2026","havard":"C.-H. Park, Y. Jeon, S. Uhlendorff, M. Pein-Hackelbusch, D.-Y. Lee, Process Analytical Technology in Upstream Mammalian Cell Cultures, in: B.D. Roitberg (Ed.), Reference Module in Life Sciences, Elsevier, [Erscheinungsort nicht ermittelbar], 2026.","van":"Park CH, Jeon Y, Uhlendorff S, Pein-Hackelbusch M, Lee DY. Process Analytical Technology in Upstream Mammalian Cell Cultures. In: Roitberg BD, editor. Reference Module in Life Sciences. [Erscheinungsort nicht ermittelbar]: Elsevier; 2026.","short":"C.-H. Park, Y. Jeon, S. Uhlendorff, M. Pein-Hackelbusch, D.-Y. Lee, in: B.D. Roitberg (Ed.), Reference Module in Life Sciences, Elsevier, [Erscheinungsort nicht ermittelbar], 2026.","ufg":"<b>Park, Cheol-Hwan u. a.</b>: Process Analytical Technology in Upstream Mammalian Cell Cultures, in: <i>Roitberg, Bernard D. (Hg.)</i>: Reference Module in Life Sciences, [Erscheinungsort nicht ermittelbar] 2026.","chicago-de":"Park, Cheol-Hwan, Yunjoo Jeon, Selina Uhlendorff, Miriam Pein-Hackelbusch und Dong-Yup Lee. 2026. Process Analytical Technology in Upstream Mammalian Cell Cultures. In: <i>Reference Module in Life Sciences</i>, hg. von Bernard D.  Roitberg. [Erscheinungsort nicht ermittelbar]: Elsevier. doi:<a href=\"https://doi.org/10.1016/b978-0-443-24738-5.00086-0\">10.1016/b978-0-443-24738-5.00086-0</a>, .","ama":"Park CH, Jeon Y, Uhlendorff S, Pein-Hackelbusch M, Lee DY. Process Analytical Technology in Upstream Mammalian Cell Cultures. In: Roitberg BD, ed. <i>Reference Module in Life Sciences</i>. Elsevier; 2026. doi:<a href=\"https://doi.org/10.1016/b978-0-443-24738-5.00086-0\">10.1016/b978-0-443-24738-5.00086-0</a>","chicago":"Park, Cheol-Hwan, Yunjoo Jeon, Selina Uhlendorff, Miriam Pein-Hackelbusch, and Dong-Yup Lee. “Process Analytical Technology in Upstream Mammalian Cell Cultures.” In <i>Reference Module in Life Sciences</i>, edited by Bernard D.  Roitberg. [Erscheinungsort nicht ermittelbar]: Elsevier, 2026. <a href=\"https://doi.org/10.1016/b978-0-443-24738-5.00086-0\">https://doi.org/10.1016/b978-0-443-24738-5.00086-0</a>.","ieee":"C.-H. Park, Y. Jeon, S. Uhlendorff, M. Pein-Hackelbusch, and D.-Y. Lee, “Process Analytical Technology in Upstream Mammalian Cell Cultures,” in <i>Reference Module in Life Sciences</i>, B. D. Roitberg, Ed. [Erscheinungsort nicht ermittelbar]: Elsevier, 2026. doi: <a href=\"https://doi.org/10.1016/b978-0-443-24738-5.00086-0\">10.1016/b978-0-443-24738-5.00086-0</a>.","bjps":"<b>Park C-H <i>et al.</i></b> (2026) Process Analytical Technology in Upstream Mammalian Cell Cultures. In Roitberg BD (ed.), <i>Reference Module in Life Sciences</i>. [Erscheinungsort nicht ermittelbar]: Elsevier.","apa":"Park, C.-H., Jeon, Y., Uhlendorff, S., Pein-Hackelbusch, M., &#38; Lee, D.-Y. (2026). Process Analytical Technology in Upstream Mammalian Cell Cultures. In B. D. Roitberg (Ed.), <i>Reference Module in Life Sciences</i>. Elsevier. <a href=\"https://doi.org/10.1016/b978-0-443-24738-5.00086-0\">https://doi.org/10.1016/b978-0-443-24738-5.00086-0</a>"},"doi":"10.1016/b978-0-443-24738-5.00086-0","editor":[{"last_name":"Roitberg","first_name":"Bernard D. ","full_name":"Roitberg, Bernard D. "}],"title":"Process Analytical Technology in Upstream Mammalian Cell Cultures","publication_status":"published","author":[{"first_name":"Cheol-Hwan","full_name":"Park, Cheol-Hwan","last_name":"Park"},{"first_name":"Yunjoo","full_name":"Jeon, Yunjoo","last_name":"Jeon"},{"last_name":"Uhlendorff","first_name":"Selina","full_name":"Uhlendorff, Selina","id":"85335"},{"id":"64952","orcid":"0000-0002-7920-0595","full_name":"Pein-Hackelbusch, Miriam","first_name":"Miriam","last_name":"Pein-Hackelbusch"},{"last_name":"Lee","full_name":"Lee, Dong-Yup","first_name":"Dong-Yup"}],"date_created":"2026-04-28T07:11:46Z","place":"[Erscheinungsort nicht ermittelbar]","language":[{"iso":"eng"}],"user_id":"83781","department":[{"_id":"DEP4028"}],"status":"public","year":"2026"}]