Search results for " market" in Articles / App Notes
Article
Flexibility in Biopharmaceutical Manufacturing
This takes operational flexibility to a different level and provides options when capital investment is at risk because of marketing forecast changes and approval uncertainty. Long construction and st…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
There are three different types of flu vaccines on the market: split virus, subunit vaccines, and live attenuated. Live, attenuated influenza vaccine (LAIV) requires less virus particles per vaccine d…
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Advancing QbD in the EU
"But the regulatory adoption of the guidelines is clarifying what elements are considered essential to support the pharmaceutical development section of a marketing authorization application dossier."…
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Bracing for a Future Wave of Advanced Therapies
As a result, both regulatory and industry are strengthening their relationship with the goal of preparing the US healthcare market for the entrance of these new products.
State of the industry
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Maximum Output Starts with Optimized Upstream Processing
…rely on the manufacturing capacity, expertise, and flexibility of CDMOs to bring their candidates to market. “With most of the drug development pipeline being held by these emerging and small biotech…
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Single-Use Technologies Prove Effective for Viral Vector Process Development
… sufficient capacity and removing the need for process change, says Marie Jourdan, vice-president of marketing and product management at Univercells Technologies.
The well-known limitations of fl…
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
What are some key guidelines for biopharma companies to follow?
Steven Lynn: I think, first off, it depends on where the company is manufacturing and marketing their products. From the US persp…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
In the EU, the market approval of a generic or biosimilar drug is not dependent on the patent status of its branded equivalent. Consequently, generic and biosimilar companies are able to launch "at ri…
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The Good and Bad of Biosimilars
Today, however, the competition is really beginning to heat up, with a rising tide of new biosimilar approvals coming from both established companies and new players, including companies in emerging m…
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Supply Chain Challenges for Single-Use Systems
Most SUS are currently made in the United States and the European Union, but suppliers are exploring manufacturing of SUS components in Asia to serve the region’s growing biopharma market more efficie…