Search results for "manufacturing"
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What is process development?
Ultimately, you will need a process that translates to a manufacturing environment, one that is easy to scale up throughout clinical trials and to the market. By the time you reach Phase III in the dr…
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Top Process Development Trends for 2021 and a Look into 2022
Further, in terms of manufacturing, because many of these molecules are so large, they are not only sensitive, but they also require closed processing.
AAV is quickly becoming the most flexible an…
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Reimagining Affordable Biosimilars
The manufacturing process itself serves as a producer of impurities and thus is a source of product heterogeneity. Characterizing and separating these impurities is essential for ensuring that product…
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Can Vaccine Development Be Safely Accelerated?
Several academic and industrial researchers have also focused on applying novel vaccine development and manufacturing platforms to the accelerated development of a COVID-19 vaccine.
In terms of…
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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…