Search results for " biologics"
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Process Chromatography: Continuous Optimization
Improved resin chemistries and customized separation solutions are enabling more efficient separations.
By Cynthia A. Challener
Cell-culture and fermentation are high-…
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Single-use Bioreactors Have Reached the Big Time
…k volume for single-use systems, the increased titers of newer cell culture processes, the growth of biologics targeting smaller patient populations and the expanding demand for biosimilars in emergi…
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Moving Biosimilars Forward in a Hesitant Market
However, it is not the same when dealing with biologics because biologics are larger and more complex molecules. Thus, to show that a product is exactly similar, that it would have the same potency, t…
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Cell-free Expression Systems Pose Cell Culture Alternative
However, the practicality of using cell-free expression systems in the commercial manufacture of biologics requires proper assessment.
Traditional cell culture struggles
Traditional …
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Biosimilar Quality Requirements
Congress created an approval pathway in the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) for biological products that are demonstrated to be “biosimilar” to or “interchangeable” w…
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A Look at the Affinity Chromatography Landscape
…ands and support systems that enable the separation and purification of not only novel protein-based biologics, but a wide range of other biomolecules, from viral vectors and nucleic acids to cells. …
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A Plastic Pipeline for Commercial Bioprocessing?
“In the old days of biologics blockbusters, the model was to have a stainless-steel facility and you supplied the world out of that. Now the model is different,” he says. “There is a lot more pressure…
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Biosimilars: Making the Switch Comes with Challenges
A major doubt is frequently their degree of comparability with the original biologics. Yet both regulators and producers believe that more could be done to eliminate uncertainties about biosimilars by…
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Aseptic Processing: Keeping it Safe
There are various schemes and equipment, however, that can support minimized interventions when manufacturing sterile biologics in a controlled environment, he says.
Environmental monitoring, when…
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Biomanufacturing Outsourcing Globalization Continues
A solid majority of biologics developers indicated in the 2015 study that they will not offshore any of their process development for biomanufacturing over that period, a result that is consistent wit…