Search results for " Design Space" in Articles / App Notes
Article
Using Quality by Design to Develop Robust Chromatographic Methods
These ranges of chromatographic variables defined a preliminary experimental design space referred to as the method operable design region (MODR).
A subsequent experimental design study (Do…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
This is particularly the case when drawing up design spaces that set the combination of variables and process parameters needed to ensure quality but have to be based on a scientific understanding of …
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
The commercialization of cell and gene therapies has become a reality, prompting deeper considerations of logistics, technology, and design for manufacturing facilities.
By Feliza Mirasol
…
Article
Right the First Time: Bioreactor Scale and Design Translation
Cell culture processes need to operate in a design space where the oxygen supply and carbon dioxide removal can match cellular metabolism. In addition, prohibitive high shear stress and high gas flow …
Article
e-Learning: what is quality by design (QbD)?
Key learnings:
- Fundamentals of the QbD concept
- How QbD fits within process development and process characterization
- Key aspects of QbD, such as the principle of design space and est…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
At this point in the process development stage, the design space has been determined. It may not be rectangular (if there are higher-order terms in the models) and may not include the entire proven ac…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Through this exercise, it will be possible to identify the process design space. The ICH guidance defines three elements--knowledge space, design space, and control space--to establish a process under…
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…
Article
Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
By using DoE, it is possible to reduce the number of cultures necessary to characterize the process design space. By reducing the ability of the model to detect higher-order interactions—so that main …