Search results for " biologics"
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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
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
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Achieving Process Balance with Perfusion Bioreactors
…with 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
Moving from one technology process during scale up to another for manufacturing creates problems, noted Peter Marks, director of the Center for Biologics Evaluation and Research at FDA, to the audienc…
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Establishment of New Modern Plasma Fractionation Facilities in Asia
This week, the Process Development Forum talks to Dr. Neil Goss, an international consultant in biotechnology and plasma fractionation, past director of Research and Development at CSL BioPlasma, Aust…
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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
QbD Improves Cell-Culture Process Control
A quality-by-design approach that implements PAT offers advantages in upstream cell-culture processing.
By Feliza Mirasol
Mar…
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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…