Search results for " market" in Articles / App Notes
Article
Continued Process Verification for Biopharma Manufacturing
…ariation and, therefore, improve process robustness and increase assurance of reliable supply to the market. Adopting or building on an existing system of monitoring manufacturing process performance…
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Challenges of Protein Aggregation During Purification
The technology was developed at the University of Colorado and is currently marketed by BaroFold under the name Pressure Enabled Protein Manufacturing (PreEMT) technology. In January 2013 and November…
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EMA Invites Comments on New Guidance for Vaccine Development
…H1N1) pandemic, requests for scientific advice received from vaccine developers and applications for marketing authorization.
The guidance provided applies to vaccines for which ample regulatory …
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Applying GMPs to the BioPharma Supply Chain
There is an acknowledged gap between current capabilities of many suppliers and what will be needed in the future to support the industry in an increasingly demanding regulatory and end-user focused m…
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A Q&A With Parrish Galliher About Adopting Single-Use Systems
There are other factors that are helping to mitigate the risk as well—smaller markets, increased titers and improved processes help shrink plant-sizes ten-fold. And, since single-use facilities are sm…
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Analyzing Proteins Using SEC, MALS, and UHPLC
“In this case,” says Daniel Some, director of marketing and a principal scientist with Wyatt Technology Corporation, “if the monomeric species is resolved from the aggregates and well-behaved in the m…
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FDA Urged to Preserve Biosimilar Naming Conventions
The practice is already established in Europe and other markets.
“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in…
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Q&As with Industry Leaders
…or of BioPharm International
Biopharmaceutical Market in Asia
Günter Jagschies, Strategic Customer Relations Leader, Cytiva
…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
More flexible management of manufacturing capacity according to market demand is also possible.
Furthermore, continuous processing facilitates quality control. For instance, many therapeutic…
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Quality by Design—Bridging the Gap between Concept and Implementation
A relatively small number of marketing approval applications made in Europe have supporting QbD data, with EMA conceding that application dossiers with QbD information are far from becoming a standard…