---
_id: '13712'
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.
author:
- first_name: Cheol-Hwan
  full_name: Park, Cheol-Hwan
  last_name: Park
- first_name: Yunjoo
  full_name: Jeon, Yunjoo
  last_name: Jeon
- first_name: Selina
  full_name: Uhlendorff, Selina
  id: '85335'
  last_name: Uhlendorff
- first_name: Miriam
  full_name: Pein-Hackelbusch, Miriam
  id: '64952'
  last_name: Pein-Hackelbusch
  orcid: 0000-0002-7920-0595
- first_name: Dong-Yup
  full_name: Lee, Dong-Yup
  last_name: Lee
citation:
  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>'
  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>
  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.'
  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>.'
  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>,
    .'
  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.'
  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>.'
  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>.
  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.'
  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.'
date_created: 2026-04-28T07:11:46Z
date_updated: 2026-04-29T11:16:34Z
department:
- _id: DEP4028
doi: 10.1016/b978-0-443-24738-5.00086-0
editor:
- first_name: 'Bernard D. '
  full_name: 'Roitberg, Bernard D. '
  last_name: Roitberg
language:
- iso: eng
place: '[Erscheinungsort nicht ermittelbar]'
publication: Reference Module in Life Sciences
publication_identifier:
  eisbn:
  - 978-0-12-809633-8
publication_status: published
publisher: Elsevier
status: public
title: Process Analytical Technology in Upstream Mammalian Cell Cultures
type: book_chapter
user_id: '83781'
year: '2026'
...