Search results for " bioprocess"
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Host-Cell Protein Measurement and Control
Therefore, it is a regulatory requirement to monitor the removal of HCPs in drug product during bioprocess development.
HCPs are proteins produced or encoded by the host organisms used to produce …
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Technologies and Practices Must Evolve to Meet Demand
As the percentage of large-molecule drugs grows, bioprocessing capabilities must keep pace with demand.
In the annual Manufacturing Trends and Outlook survey, the editors of BioPharm International…
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Raw Material Variability
It would seem that raw materials used in bioprocessing operations are a relatively straightforward factor given the overall complexity of commercial manufacturing. In fact, they give a surprisingly di…
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Innovative Chromatography Resins Can Improve Purity and Quality
“The problem is that, with every DSP step, product yields decrease, while bioprocessing time and equipment occupancy goes up, along with DSP manufacturing risks,” Schub says.
He also emphasizes th…
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Updating Viral Clearance for New Biologic Modalities
Clearance challenges
The challenge of demonstrating viral clearance in downstream bioprocessing depends on multiple factors. For most traditional biological products, viral removal is theoretical—…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
This week, Bioprocess Development Forum spoke with Tobias Hahn, PhD, co-founder and CEO of GoSilico, about the opportunities of mechanistic modeling in bioprocess development, now and in the future.
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Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
… buffer concentrates with in-line dilution or conditioning systems can significantly help streamline bioprocessing operations.
Improving the efficiency and productivity of buffer preparati…
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Cell-Culture Advances Test Bioreactor Performance Models
“While some vendors already offer such sparger technologies, the industry has been slow to update to these sparger technologies, likely due to the revalidation burden of changes to established bioproc…
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Design Considerations for a Commercial Cell and Gene Therapy Facility
For mAb bioprocessing and viral-vector manufacturing, the equipment needed is similar, such as single-use bioreactors and standard harvest and downstream systems for clarification, tangential flow fil…
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What’s New in Upstream Technologies
Buffer delivery component
MilliporeSigma’s BioContinuum Buffer Delivery Platform, a new component in the company’s BioContinuum Platform for next-generation bioprocessing, offers a way to streamli…