Search results for "biologic"
Article
SEC in the Modern Downstream Purification Process
Another benefit of using SEC is that the biological activity of the target of interest is preserved throughout the separation process, particularly if the target of interest requires that its quaterna…
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Fermentation for the Future
Notably, the technology can be used to produce proteins incorporating non-natural amino acids and for the production of challenging biologic substances, such as difficult-to-fold proteins. In addition…
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What Drove Biopharma Development in 2014?
As federal agencies continue to push for proof of quality in biologics, there is increased interest in, and use of, QbD in pharmaceutical development and that trend is only expected to rise. According…
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Optimizing Resin Performance with Disposable Chromatography Solutions
Materials based on synthesized polymers may have higher levels of extractable components, or may nonspecifically bind biological molecules via ionic or hydrophobic interactions. Regardless, the materi…
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DoE Provides Benefits, but Preparation Is Necessary
…rtant early in the development of a biopharmaceutical product given the limited availability of the biologic API. Further, a DoE approach can be particularly useful for combination products that have…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part 2
Can you identify geographical or company size differences in who is using QbD?
Since the early push for QbD implementation in biologics came from the U.S. FDA, major manufacturers based in North Am…
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Using Quality by Design to Develop Robust Chromatographic Methods
Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) (2012).
5. M. Schweitzer, et al., Pharm. Technol. Eur. 22 (2) 29-37 (2010).
6. V.R. …
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Single-Domain Antibodies for Brain Targeting
Going single domain
Biologic therapies such as monoclonal antibodies (mAbs) are enabling the targeted, personalized treatment of cancer, inflammatory diseases, infectious diseases, and diseases of…
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Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
An upside to this model is that many breakthrough biologics and innovative platforms are coming from small, start-up research companies, but their resources are limited. To get involved in development…
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Global Expansion Shapes Drug Oversight
…ector of the Center for Drug Evaluation and Research, and Karen Midthun, director of the Center for Biologics Evaluation and Research, unveiled a new initiative to collaborate more with EMA and Europ…