Powered by OpenAIRE graph
Found an issue? Give us feedback
Computer Fraud & Sec...arrow_drop_down
Computer Fraud & Security
Article . 2026 . Peer-reviewed
Data sources: Crossref
ZENODO
Article . 2026
License: CC BY
Data sources: Datacite
ZENODO
Article . 2026
License: CC BY
Data sources: Datacite
versions View all 3 versions
addClaim

Advanced Control Architectures for Single-Use Bioreactors in Cell and Gene Therapy Manufacturing

Authors: Prashant Mavani;

Advanced Control Architectures for Single-Use Bioreactors in Cell and Gene Therapy Manufacturing

Abstract

A paradigm shift of the biopharmaceutical industry has been seen in the movement towards cell and gene therapy production, where there is a need to adopt sophisticated and state-of-the-art single-use bioreactor systems with complex automation architectures. This academic paper provides a detailed outline of hierarchical control measures to be applied in the single-use bioreactor systems, in particular, that have to face the challenges of compliant film materials, restrictions of sensors, and dynamic working conditions. The article explores fundamental process control elements, including dissolved oxygen regulation, pH management, temperature stability, and agitation control, while examining the integration of continuous perfusion systems utilizing alternating tangential flow technology and discrete media exchange protocols coordinated with centrifugation equipment. Emphasis is placed on the systematic development of recipe-layer architectures that enable process scientists to configure complex operational sequences through parameterized phases rather than direct control code modification, thereby maintaining validation status across diverse therapeutic products and manufacturing scales. The control strategies discussed enable process intensification, achieving substantially higher cell densities and volumetric productivities while maintaining product quality attributes essential for viral vector production, engineered cell therapies, and stem-cell-derived therapeutics. The framework addresses critical regulatory considerations, including data integrity, electronic batch record integration, and risk mitigation strategies for potential failure modes. As the field advances toward increasingly complex cellular products and automated manufacturing paradigms, the automation architectures presented serve as foundational elements supporting the transition from traditional bioprocessing toward intelligent, adaptive manufacturing systems capable of responding to biological variability and process dynamics in real-time.

  • BIP!
    Impact byBIP!
    selected citations
    These citations are derived from selected sources.
    This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    0
    popularity
    This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
    Average
    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
    Average
    impulse
    This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
    Average
Powered by OpenAIRE graph
Found an issue? Give us feedback
selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
Upload OA version
Are you the author of this publication? Upload your Open Access version to Zenodo!
It’s fast and easy, just two clicks!