Search results for " opportunity" in Articles / App Notes
Article
Drugs, At What Cost?
Generics, market dynamics, and global demand are changing drug spending patterns.
The underlying question for any drug in development is: What price can (or will) patients pay for the needed…
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Best Practices in Adopting Single-Use Systems
Key considerations for implementing single-use components or platforms when moving from research to process development.
The adoption of single-use systems in biopharmaceutical production or…
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Navigating Emerging Markets: Middle East and North Africa
The pharmaceutical industry grows despite conflict in the Middle East.
The Middle East and North Africa have been rocked in recent years by upheaval ranging from moderate protest to full…
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Prescribing Caution for Biosimilars
We welcome the opportunity to further discuss this issue with lawmakers as they seek to address vital drug safety measures that accompany this cutting-edge technology.
James C. Greenwood, Presiden…
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Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Timelines are often built without an opportunity to identify crucial aspects of the process, perform range finding experiments, or optimize the process. Additionally, fears of making "process changes"…
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Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Single-use systems allow for quick changeover between campaigns with the opportunity to produce more batches per year. Optimized facility utilization is the key to minimizing production costs and pote…
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Advancing QbD in the EU
EU authorities are stepping up their efforts to incorporate QbD principles.
The European Commission (EC) and the European Medicines Agency (EMA), have been supporting quality-by-design (QbD)…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
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Quality by design for biotechnology products—part 1
This situation is expected to provide an opportunity for manufacturing to incorporate new technology more quickly and easily and to make changes within the design space without regulatory agency revie…