Search results for " validation" in Articles / App Notes
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…
Article
Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
Article
Viral Clearance: 7 Chromatography Column Considerations
Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging.
Here are seven things to conside…
Article
Single-Use for Downstream Chromatography: Benefit or Hindrance?
Single-use technology is gaining ground in downstream bioprocessing, but challenges stall further adoption.
By Feliza Mirasol
ARTMOIS/STOCK.ADOBE.COM
Biopharmaceutical manufactu…
Article
Fundamentals of Viral Clearance Studies with a Focus on Chromatography
These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatog…