Search results for " scaling" in Articles / App Notes
Article
Scaling a mAb Production Process to Xcellerex Bioreactors
This article discusses moving a monoclonal antibody (mAb) production process from a microscale bioreactor to the Xcellerex XDR single-use platform.
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Being Thorough When Transferring Technology
The challenges of scale up and tech transfer of biologics
BioPharm: What are the challenges when scaling up from lab scale to commercial scale in biologics?
Moscariello and Young (CMC Biologic…
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Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
The development of breakthrough FBRs bring new opportunities in readily developing and scaling adherent platforms as an alternative to STRs. FBRs provide a support matrix for cell adherence while allo…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
…rs, while fixed-bed culture systems and stirred-tank bioreactors are the predominantly leveraged for scaling adherent and suspension processes, respectively,” Tan says. Use of microcarriers that supp…
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Mapping a Route for Cell and Gene Therapy Process Development
cell therapy applications), the focus of scaling of the manufacturing process may be different.
Scale up and mass production of the final product starting from a small seed bank (for instance, …
Article
Tools for Continuous Bioprocessing Development
The physical and chemical environment of the cells can strongly affect the cells’ physiology and productivity and, hence, must remain constant or above critical values during scaling.
First, the ga…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
As a final note on scaling viral-vector sterile filtration processes, Laux points out that at CSL, it has been observed that not the volume, but the number of virus particles per filter area is the cr…
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Using Digital Twins to Model Process Chromatography
Mechanistic models provide process understanding for developing robust manufacturing processes and for scale up and tech transfer.
By Jennifer Markarian
A digital twin is a model of a proces…
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Platform Approach Speeds Process Development
A modular cell-culture platform demonstrates accelerated process development.
By Harald Bradl, Jan Bechmann, Benedikt Greulich, Markus Michael Mueller, Patrick Schulz, Thomas Wucherpfennig
C…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Substantial prior experience with scaling particular unit operations may provide key information such as dimensionless parameter groups and scaling equations.
Areas considered for experimental sca…