Search results for "Science"
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Modular Manufacturing Platforms for Biologics
According to Michael O’Brien, vice-president of Pfizer Pharmaceutical Sciences Technology & Innovation Group, who spoke about the units at the 2015 Parenteral Drug Association Annual (PDA) Meeting on …
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Drug Discovery and Development in India
According to a study into life-sciences venture capital published in 2013, only 32 out of a surveyed 170 biotechnology firms in India were backed by venture capital (2).
Market challenges
Phar…
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Vaccine Development and Production Challenges Manufacturers
Protein Sciences’ new Flublok vaccine uses a faster process, and the company hopes to expand production over the coming year. Novartis’ vaccine plant in Holly Springs, NC was recently licensed to prod…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
The very nature of aggregation is challenging, says St John Skilton, senior global market manager of biologics at SCIEX, a life-science analytical technologies company. The fact that aggregation is “d…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Mark, Encyclopedia of Polymer Science and Technology (John Wiley, Hoboken, NJ, vol. 2, 2003), pp. 49
About the Authors
Sara Ullsten, PhD is bioprocess project manager; Eva Lindskog, PhD, is up…
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Optimizing Resin Performance with Disposable Chromatography Solutions
Resin structure is a science in itself. Many resins use the same or similar ligands, but perform quite differently in use, such that manufacturers must balance a number of factors in order to optimize…
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New Era for Generic Drugs
…crance, then acting deputy director for generic drug chemistry in CDER’s Office of Pharmaceutical Science (OPS), at the FDA/PQRI conference in September 2014. The risk-based review approach has alrea…
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High-Throughput Process Development in an Historical Environment
Cornelia Walther from University of Natural Resources and Life Sciences in Vienna, Austria, presented work on refolding of inclusion bodies. Traditionally, optimization of the refolding steps has been…
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DoE Provides Benefits, but Preparation Is Necessary
LaBrenz, scientific director, pharmaceutical development and manufacturing sciences with Janssen Research & Development. At the same time, DoE results depend on the selected critical parameters and th…
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Application of Quality by Design to Viral Safety
QbD functions across the lifecycle of the product and integrates sound science with risk management. This approach uses the concepts laid out in the International Conference on Harmonisation of Techni…