Search results for " Biopharm" in Articles / App Notes
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Peterson, J Biopharm. Stat. 18 (5) 959-975 (2008).
6. ASTM, E2500-07, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and E…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Mitchell, BioPharm International 26 (12) 38-47 (2013).
Mark Mitchell is principal engineer at Pharmatech Associates.
Article
Operational Excellence: More Than Just Process Improvement
However, that approach forgoes the improvements in efficiency, reliability, and the reductions in costs biopharmaceutical organizations can ill afford to sacrifice. And the result of gold plating will…
Article
Regulatory Challenges in the QbD Paradigm
This article is part of a special section on biopharmaceutical trends.
With the dawn of the 21st century came the realization that changes must be made by both the pharmaceutical industry…
Article
Welcome to the new Process Development Forum
Process Development Forum is a joint venture between Cytiva and BioPharm International magazine. Our team welcomes you to the site; please let us know what you think. We welcome your feedback.
The…
Article
Flexibility in Biopharmaceutical Manufacturing
Compared to other industries, biopharmaceutical supply chains have been stuffed with inventory that effectively decouples manufacturing supply from customer demand. This makes the job of running the p…
Article
Quality Considerations for Using AI in Bio/Pharma
The use of artificial intelligence (AI) is seeing a surge in a variety of industries. But does the regulated nature of bio/pharmaceutical development, manufacturing, and commercialization ser…
Article
Downstream Process Developers: What are Your Antibody Processing Challenges?
Process developers, we want to hear from you! We're asking PD scientists to tell us about their biggest challenges developing downstream processes for mAbs and their variants.
Take this …
Article
Top Tips for Successful Development of Antibody Chromatography Processes
… Transcript
Jeanne Linke Northrop: Hello, I'm Jeanne Linke Northrop, Managing Editor with BioPharm International. I'm joined today by Jakob Liderfelt, a Global Product Manager for monoclon…
Article
Boosting biopharma resilience: The need to shift focus and increase collaboration
The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength and opportunities for collaborative growth. By …