Search results for "biologic"
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2019’s Top Bioprocessing Trends and What to Expect in 2020
2019 proved to be an exciting year for biopharmaceutical developers and process engineers, filled with both advancements and lessons. Considering how far the industry has come, what direction will 2…
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Science Focus Fuels Successful Process Development for Startups
“There are no established protocols for how to go about process development for cell therapies, unlike for conventional biologics and small-molecule drugs. We are engineering patient cells to produce …
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Another significant challenge with biosimilars as well as other biological products is that of standardizing the Fc receptor binding. Fc receptors can be activating, or inhibitory, or without any effe…
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Achieving Process Balance with Perfusion Bioreactors
…ith 100% product transmission under typical process conditions used in the continuous production of biologics,” he notes.
Sartorius Stedim Biotech is working with Repligen to develop integration …
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Optimizing Late-Stage and Commercial Cell-Culture Processes
Cell-culture evolution
Current cell-culture processing has been optimized and has resulted in significantly higher cell densities compared to biologics manufacturing in the past. In the early 1990…
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Biopharma Seeks Balance
FDA reports that it has considered emerging technologies for biological molecules including controlled ice nucleation for lyophilization processes, predictive modeling for process monitoring and close…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
…ommercial forum for the exchange of concepts, ideas, and information relating to the manufacture of biological products in the Asian region. The inclusion of a specific plasma fractionation session i…
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Process Development: What May Lie Ahead in 2018?
While only 22 new drugs were approved in 2016, FDA gave its thumbs up to 46 new drugs in 2017 (of which approximately one-quarter were biologics). The figures for all new drug approvals are in line wi…
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QbD Improves Cell-Culture Process Control
By applying advanced sensor systems combined with mathematical modeling techniques, one can gain an enhanced understanding of the processes that produce the biologic product.
In addition, this …
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Roadmap Leads to Innovative Biomanufacturing Strategies
Biomanufacturers are uniquely aware of the challenges faced during development and manufacturing of biologics and they are in the best position to communicate their needs to the suppliers and academic…