Search results for " development" in Articles / App Notes
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Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
One possibility is in the development of biosimilar products. President Trump has promised to repeal and replace the Affordable Care Act (ACA), but what impact might this have on biosimilar developmen…
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Establishing Acceptance Criteria for Analytical Methods
This is particularly of interest during early development when product specification limits (Q6B) are not yet available. The penalty for solely depending on CV or % recovery is a method may be develop…
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Best Practices in Qualification of Single-Use Systems
SUS Process Development
Single-use systems are being used in almost all stages of biomanufacturing processes, including upstream, downstream, and fill/finish operations. Figure 1 depicts a typical…
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Modular Manufacturing Platforms for Biologics
Mike Booker, manager of business development at PortaFab, a manufacturer of cleanroom wall systems and other modular cleanroom products, says the company has a Mid-West pharmaceutical client that uses…
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Continuous Manufacturing: A Changing Processing Paradigm
Costs and benefits of continuous manufacturing
The complexity of continuous manufacturing could make the switch unattractive to prospective users, and there are also concerns surrounding process d…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
The concept of concentrated media was applied in the development of a feed medium for the process of cell line C. A feed medium was developed by concentrating the original feed medium to 7.5 fold, des…
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The Affordable Care Act's Impact on Innovation in Biopharma
Even more important is that influencing decisions like what choices go on the formulary will require an entirely new approach to business development that doesn’t begin to resemble physician detailing…
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Trends in Downstream Bioprocessing
…eck problem
• New processes being introduced could create downstream-related delays at process development stage.
By contrast, prior year comments included more detail and more indication of …
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Evaluating the Use of Continuous Chromatography
But to increase efficiency and promote flexibility, biomanufacturers are looking to implement continuous downstream process development. However, despite successful laboratory trials, it has remained …
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Determining and Optimizing Dynamic Binding Capacity
Determination and optimization of this value facilitates the development of efficient and productive chromatography operations. While the same general method is used to determine the DBC for many diff…