Search results for " continuous"
Article
High-Throughput Process Development in an Historical Environment
Presentations, discussions, and information-sharing on modern bioprocess technology and high-throughput process development (HTPD) in an historical and culturally enriched environment is the essence…
Article
A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
This two-part Q&A series with Anurag Rathore, PhD, Professor, Department of Chemical Engineering, Indian Institute of Technology, Delhi, reveals the evolution of QbD, the types of companies implemen…
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…
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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
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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…
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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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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…