Search results for " process"
Article
Addressing the Complex Nature of Downstream Processing with QbD
Critical material attributes (CMAs) and critical process parameters (CPPs) are identified through product design and understanding. Specifications for the drug substance, excipients, and drug product …
Article
Technology Innovations Improve Process Chromatography Performance
Biomanufacturers consider several key factors when selecting a best-fit process chromatography technology for their products, including the stability of the biologic, compatibility of the buffers used…
Article
Platform Approach Speeds Process Development
Chinese hamster ovary (CHO)-based cell culture platforms should combine state-of the-art technologies for genetic vectors, host cell portfolio, cell line generation, cultivation media, and process des…
Article
Reducing Cross-Contamination Risks in Process Chromatography
Single-use solutions for process chromatography are no exception and offer distinct advantages over permanent, stainless-steel systems in many circumstances.
Reducing risk
Manufacturer…
Article
Continuous Processing for the Production of Biopharmaceuticals
By Anurag Rathore, Nikhil Kateja, Harshit Agarwal, Abhishek Kumar Sharma
Benefits of continuous processing have been widely demonstrated by a variety of manufacturing industries. With the growing …
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Increasing upstream titers and shrinking development timelines have posed several challenges to downstream process development of mAbs. Some of the major strategies and tools to address these challeng…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
Over the years, cell-culture processes have evolved to achieve optimum production yield and quality for both clinical development and commercial manufacturing.
Cell-culture evolution
Current c…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Second, better systems for collecting, storing, and analyzing process data have facilitated the application of multivariate data analysis (MVDA) to historical bioprocess data. These developments have …
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
The trend toward personalized medicines includes more complex manufacturing cycles that can benefit from advanced process modeling early on in the therapeutics’ development.
By Feli…
Article
Leveraging Data for Better Biopharmaceutical Process Control
By Agnes Shanley
Upstream biopharmaceutical manufacturing has always depended on process measurements, because precise levels of nutrients and oxygen must be monitored closely to e…