Search results for " Design Space" in Articles / App Notes
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion (specification limits) is crucial in design space generation and use. Design space is proposed by the applicant and is subject to regulatory assess…
Article
Robust Optimization, Simulation, and Effective Design Space
Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of a design space are explored.
…
Article
Evaluating Design Margin, Edge of Failure and Process
46-49
A product’s or process’ design space is generally considered to be the area where process parameters safely (without failure or high amounts of degradation) can be processed and achieve al…
Article
Quality by design for biotechnology products—part 1
…entifying critical quality attributes and setting specifications, followed by the development of the design space and establishing the process control strategy; to later stages, including incorporati…
Article
Application of Quality by Design to Viral Safety
Identification of a multivariate design space in which data support the impact that multidimensional process parameter ranges will have on critical quality parameters enables process consistency. The …
Article
Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design.
Sep 1, 2014
By: Susan Haigney
BioPharm International
Volu…
Article
Design of Experiments for Analytical Method Development and Validation
…n or concentration will not require additional validation as they are changes within a characterized design space. Once methods have been developed, qualified, and validated, the impact they have on …
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
Each CQA then serves as a dimension in the establishment of a multidimensional design space that provides a full understanding of process impact on product quality.
Process control strategy (PCS…
Article
Quality by Design and Extractable and Leachable Testing
The relationship between the materials selected, the manufacturing process, and critical quality attributes are described in the design space. This defined relationship will provide assurance of quali…