Search results for " validation"
Article
Remote Monitoring and Big Data Advance Upstream Automation
“The desire to produce ‘batches of one’ presents very special automation challenges when it comes to both automation and batch validation,” he continues. Engineered solutions utilizing closed systems …
Article
Testa Challenge 2020 Attracts Leading International Bioprocessing Innovators
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Six bioprocessing innovators have successfully completed the inaugural Testa Challenge 2020. Held over an intensive week in the Testa Center located at Cytiva´s Uppsala…
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Article
Improving mAb Manufacturing Productivity by Optimizing Buffer and Media Prep Process Flow
Innovative approaches, including ready-to-use materials and in-line dilution, can significantly streamline overall bioprocessing operations.
By: Pranav Vengsarkar and Nandu Deorkar
I…
Article
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
…rocess development control challenges
- Process development general challenges
- Validation challenges
- Need for greater process control
- Cell line stability…
Article
Flexible Facilities for Viral Vector Manufacturing
Murphy says the primary benefit for single-use systems is eliminating the need to perform cleaning validation on reused product contact equipment.
References
1. C. Challener, Pharm.Tech. 43 (9…
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
FDA’s quality-by-design (QbD) and validation initiatives also encourage the use of modeling early on.
While QbD does not define manufacturing design space or specific protocols, it does discuss…
Article
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
Legal experts in biopharmaceutical patent law shed some light on trends and recent news.
By Agnes Shanley
…
Article
Monitoring and Control of Inline Dilution Processes
Buffer management has received less attention in process intensification despite the high costs and labor-, space-, time-, and material-intensive nature of this common downstream activity.
By…
Article
Getting it Right from the Start in the Drug Development Process
Proper process understanding allows researchers to critically identify factors that impact the drug substance and product as well as minimize or maintain them at approved levels. As a result, the de…