Search results for " small-scale"
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Establishing similar run conditions at multiple scales is an important consideration when trying to qualify the comparability between full-scale and small-scale experiments. Substantial prior experien…
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Updating Viral Clearance for New Biologic Modalities
“The vital principle is that the small-scale model used for the viral clearance study must represent the manufacturing-scale operation,” he says, “and ideally it should represent a ‘worst case’ scenar…
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Industry Adoption of Single-Use Systems Remains Low
“Small-scale, single-use systems are already in widespread use for process development and small-scale expansion of cell cultures and downstream processing. Therefore, we expect evolutionary, not revo…
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Development of Purification for Challenging Fc-Fusion Proteins
In this study, utilizing a combination of high-throughput condition screening in 96-well plates, optimization in small-scale column models, and a novel virus-spiking strategy, the authors have develop…
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Being Thorough When Transferring Technology
Next-generation harvest technologies, including flocculation with cell settling and microfiltration, are being implemented, and the data are limited regarding the utility of their small-scale models. …
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Tools for Continuous Bioprocessing Development
If the large-scale bioreactor is well characterized, a small-scale system can be used to replicate all of its operating conditions and potential variations. Proper scale down requires good simulation …
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Single-Use Technologies Prove Effective for Viral Vector Process Development
“Traditional laboratory-scale systems, such as roller bottles or cell factories designed for use with adherent cells, are generally used for small-scale production of viral vectors, while fixed-bed cu…
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Innovative Chromatography Resins Can Improve Purity and Quality
We then couple the selected ligand to chromatography beads and deliver small-scale samples to the client to confirm custom affinity resin performance in-house,” says Schub. “Subsequent resin scale-up …
Resource
Protein A Fiber Chromatography from Research to Scale-up and Manufacturing of Monoclonal Antibodies
This makes the pre-packed, small-scale Protein A fiber unit a versatile tool for processes such as clone selection and upstream cell-culture media development. The time savings in downstream processes…
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FDA Framework Spurs Advanced Therapies
The reason: with current available technology, early-stage clinical material will for the most part be manufactured with manual, small-scale methods. “Parallel development of processes that provide up…