Search results for " continuous" in Articles / App Notes

Article Healthcare Reform in China
Chinese healthcare reforms may be a double-edged sword for foreign companies. Sep 1, 2014 By: Jane Wan BioPharm International Volume 27, Issue 9, pp. 8-12  On March 25, 2014, the…

Article Applying GMPs to the BioPharma Supply Chain
Suppliers need to understand how eliminating sources of variation is crucial for continuous improvement. They need to understand how variability in raw material quality can have a significant downstre…

Article Q&As with Industry Leaders
…onal  Developments in Continuous Processing Konstantin Konstantinov, VP Lat…

Article Quality by Design—Bridging the Gap between Concept and Implementation
Other major issues emerging at the conference, which focused on six case studies of QbD submissions evaluated by EMA, included real-time release testing (RTRT), application of QbD to continuous manufa…

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…

Article Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Furthermore, processes will be more robust and continuous improvement opportunities more easily identified. In Part I of this series, the author used risk analysis and applied the continuum of …

Article Supplier-Change Management for Drug-Product Manufacturers
Conclusion Pharmaceutical manufacturers and the suppliers that they rely on operate in a world of continuous improvement, and any improvement will result in change. The objective of continuous imp…

Article Operational Excellence: More Than Just Process Improvement
At the site, operational excellence is now seen as a process of continuous operational, quality, and compliance improvement, where everyone understands the organization’s objectives, policies, and pro…

Article The Development and Application of a Monoclonal Antibody Purification Platform
During scale-up, we noted that effective filtration required a much larger membrane area than was feasible, so we introduced a continuous flow centrifugation process, followed by depth filtration to m…

Article Innovations in Perfusion Bioprocessing
Furthermore, we illustrate the successful transfer of the developed perfusion process from small-scale applications to an integrated continuous bioprocess at a 50 L pilot scale Learn more

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