Search results for " design"
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Examples of statistical models of TGP glycosylation are design of experiment (DoE) surface response models (23) and partial least squares regression (33,34). Advantages of statistical models are that …
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An Analytical Approach to Biosimilar Drug Development
As a result, demand has increased for chromatography and mass spectrometry technology providers to design instrumentation, software informatics, and workflows to support protein analysis studies. In a…
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Scaling Up Novel Therapies
In addition, they permit some degree of facility design standardization, improving operational flexibility and capital savings, he says.
Developers are exploring how these platforms might…
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Making the Move to Continuous Chromatography
Continuous chromatography systems are designed to be loaded continuously, which is a useful approach when the purification step is connected to an upstream perfusion bioreactor. There are several diff…
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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…
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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…