Search results for "manufacturing" in Articles / App Notes
Article
Monitoring and Control of Inline Dilution Processes
Inline dilution (ILD) combined with inline conditioning (IC) is one of the key ways to intensify downstream processes, according to Avril Vermunt, program manager for connected biomanufacturing at Cyt…
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A Look into the Future of Biopharmaceutical Quality
Some of these are autologous products using a patient’s own blood components and personalized medicines can present additional manufacturing, compliance, and regulatory challenges.
Quality Control…
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Going Viral
Manufacturing viral vector-based therapies such as vaccines and gene and cell therapies is complex, but a new manufacturing solution helps solve those challenges. The new KUBio BSL-2 solution for vira…
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Applying GMPs in Stages of Development
We have clients with products in various stages of development that are using multiple contracts with multiple services providers for various stages of the manufacturing process. I always struggle wit…
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Ensuring the Biological Integrity of Raw Materials
“Essentially, it’s about knowing your manufacturing process, knowing your raw materials, and going deep. Understand exactly what the risks are, then try and mitigate the risk,” Lovatt says. That would…
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CMOs Continue to Improve Overall Biomanufacturing Performance
By Eric Langer
Biomanufacturing efficiency is on everyone’s minds, being the single most important area of focus for global bioprocessing. And contract manufacturing organizations (CMOs) are on th…
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SEC in the Modern Downstream Purification Process
Despite the relative predictability of SEC separations, method development at small scale is crucial to ensure a smooth transition from the bench- to manufacturing-scale operations.
With SEC, it i…
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FDA Approves First Biosimilar
Manufacturing considerations
While Novartis says no immunogenicity or antibodies against rhG-CSF were detected throughout the head-to-head PIONEER study, immunogenicity issues can be introduced at…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
All of this testing extends the production time and increases the manufacturing cost.
Cell-culture technology
Cell-culture technology enables the use of raw materials that are readily ava…
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Operational Excellence: More Than Just Process Improvement
Not the least of these sustainable benefits are improved quality and compliance
Consider another vaccine manufacturer that faced recurring compliance problems in two key manufacturing operations. T…