Search results for " market"
Article
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…
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FDA and EMA Extend QbD Parallel-Assessment Pilot Program
The program is open to applications for initial marketing authorizations, type-II variations, and scientific advice. Participation in the pilot is voluntary, and applicants should contact both FDA and…
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State of Quality and Compliance in the Biopharmaceutical Industry
…e—and the first line of defense to assure the uninterrupted supply of high-quality products to the market. Manufacturing can't be successful on its own. The quality unit is needed to help assure the …
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Operational Excellence: More Than Just Process Improvement
A program focused on new product introductions reduced time to market by 40%. For another manufacturer, a site-wide program generated $20 million in savings the first year and a 50% reduction in throu…