Process Analytical Technology in Upstream Mammalian Cell Cultures

book chapter Process Analytical Technology in Upstream Mammalian Cell Cultures published CHe Cheol-Hwan Park author Yunjoo Jeon author Selina Uhlendorff author 85335 Miriam Pein-Hackelbusch author 649520000-0002-7920-0595 Dong-Yup Lee author Bernard D. Roitberg editor DEP4028 department 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. Elsevier2026 eng Reference Module in Life Sciences10.1016/b978-0-443-24738-5.00086-0 Park, C.-H., Jeon, Y., Uhlendorff, S., Pein-Hackelbusch, M., & Lee, D.-Y. (2026). Process Analytical Technology in Upstream Mammalian Cell Cultures. In B. D. Roitberg (Ed.), Reference Module in Life Sciences. 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>

Park, Cheol-Hwan ; Jeon, Yunjoo ; Uhlendorff, Selina ; Pein-Hackelbusch, Miriam ; Lee, Dong-Yup: Process Analytical Technology in Upstream Mammalian Cell Cultures. In: Roitberg, B. D. (Hrsg.): Reference Module in Life Sciences. [Erscheinungsort nicht ermittelbar] : Elsevier, 2026

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. Park, Cheol-Hwan, Yunjoo Jeon, Selina Uhlendorff, Miriam Pein-Hackelbusch, and Dong-Yup Lee. “Process Analytical Technology in Upstream Mammalian Cell Cultures.” In Reference Module in Life Sciences, 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>. Park CH, Jeon Y, Uhlendorff S, Pein-Hackelbusch M, Lee DY. Process Analytical Technology in Upstream Mammalian Cell Cultures. In: Roitberg BD, ed. Reference Module in Life Sciences. 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> C.-H. Park, Y. Jeon, S. Uhlendorff, M. Pein-Hackelbusch, and D.-Y. Lee, “Process Analytical Technology in Upstream Mammalian Cell Cultures,” in Reference Module in Life Sciences, 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>. Park C-H et al. (2026) Process Analytical Technology in Upstream Mammalian Cell Cultures. In Roitberg BD (ed.), Reference Module in Life Sciences. [Erscheinungsort nicht ermittelbar]: Elsevier. Park, Cheol-Hwan u. a.: Process Analytical Technology in Upstream Mammalian Cell Cultures, in: Roitberg, Bernard D. (Hg.): Reference Module in Life Sciences, [Erscheinungsort nicht ermittelbar] 2026. 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.

Park, Cheol-Hwan, Yunjoo Jeon, Selina Uhlendorff, Miriam Pein-Hackelbusch und Dong-Yup Lee. 2026. Process Analytical Technology in Upstream Mammalian Cell Cultures. In: Reference Module in Life Sciences, 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>, .

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. Park, Cheol-Hwan, et al. “Process Analytical Technology in Upstream Mammalian Cell Cultures.” Reference Module in Life Sciences, 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>. 137122026-04-28T07:11:46Z2026-04-29T11:16:34Z