Search results for " equipment"
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Fusion Proteins Pose Manufacturability Challenges
Solutions for overcoming these issues are being developed in academia and the pharmaceutical industry by equipment vendors and drug companies alike.
Making proteins ‘druggable’
Many proteins…
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Single-use Bioreactors Have Reached the Big Time
“[Cytiva] is taking its experience in single-use bioreactor technologies for monoclonal antibody, recombinant protein, and vaccine processes and applying it in our Xuri line of cell therapy equipment …
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Reconciling Sensor Communication Gaps
Widespread familiarity with single-use equipment has greatly improved prospects for continuous unit operations and elevated “continuous” to official buzzword status. With continuous processing comes n…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…
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Ensuring the Biological Integrity of Raw Materials
Thorough cleaning of equipment, testing, and review of material sources are also important steps to take. Bovine serum, for example, should be sourced from a country with a negligible risk of bovine s…
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Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
At larger scales, however, conventional chromatography, using stainless steel equipment, can still be a beneficial alternative. Here, we compare the performance of the disposable ReadyToProcess Adsorb…
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Efforts Accelerate to Streamline Postapproval Change Process
Change challenging
Manufacturers typically make dozens of routine changes in facilities, equipment, processes, and testing every year for every product; the vast majority are minor and managed wit…
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Modeling Bioreactor Performance
Clapp also stresses that off-the-shelf products only provide the engine for modeling; the user, equipment supplier, or third-party service provider must have the capability to create a model and perfo…
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Downstream Processing Continues to Worry CMOs
Some of the biggest gaps between these groups relate to developing processes with fewer steps and to using single-use equipment in downstream processing. Indeed, a majority of CMOs are considering usi…
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Maximize resin usage with continuous bioprocessing
PCC increases the use of available resin and enables smaller equipment footprint and shorter processing times compared with batch processing.
To learn more about continuous chromatography, and oth…