Search results for " design" in Articles / App Notes
Article
Industry Adoption of Single-Use Systems Remains Low
…lace the glass bottles or stainless-steel vessels traditionally used for sterile-fluid handling, are designed to save space and provide ease of maneuverability around the facility (4). Because they a…
Article
FDA Framework Spurs Advanced Therapies
The framework also implements the Regenerative Medicine Advanced Therapy (RMAT) designation program as required by the 21st Century Cures Act. This program is designed to expedite the development and …
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QbD Improves Cell-Culture Process Control
Once those steps have been developed, operators can determine the relationships between critical process parameters and product quality attributes by applying statistical design experiments, multivari…
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Reducing Cross-Contamination Risks in Process Chromatography
Single-use system suppliers have developed products that are designed to work in conjunction with stainless-steel equipment, according to Bulpin. MilliporeSigma, for instance, offers single-use chroma…
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Process Chromatography: Continuous Optimization
Multimodal resins most often separate molecules based on ligand properties, but there are examples of multimodal resins for which the base matrix design contributes to the separation. Cytiva has, for …
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Witnessing Major Growth in Next-Generation Antibodies
Challener
Next-generation antibodies are designed to be more specific and are often more potent than traditional monoclonal antibodies (mAbs). As a result, their commercial potential is significan…
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Reconciling Sensor Communication Gaps
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors and probes. Single-use systems …
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Automating Bioprocesses
With traditional systems, sensors were designed to be highly accurate, long-lasting devices. In SUS, these sensors would be too expensive, because the sensor only needs to last for one batch. Disposab…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
Custom designed stainless-steel cases lined with foam padding (designed to protect the bags while in the frozen state) were used as containers for the ~8.3 L bags during storage and handling.
Size…
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Improving Process-Scale Chromatography
For example, Cytiva is currently using high-throughput screening techniques to screen hundreds of ligand designs with the goal of further improving process economy and robustness in mAb manufacturing …