Search results for "design of experiments"

Article Essentials in Establishing and Using Design Space
Misconception One: Design of experiments is the same as design space Design of experiments (DOE) is not the only method for determining a design space. Other methods can be used including know…

Article Robust Optimization, Simulation, and Effective Design Space
Design of experiments (DOE) and other multivariate analysis techniques assist the developer in mapping out the design space and building process models. Once the DOE is complete, the developer can use…

Article Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development. Sep 1, 2014 By: Thomas A. Little, PhD BioPharm International Volume 27, Issue 9, pp. 46-49 A product’s or proc…

Article Quality by design for biotechnology products—part 1
A risk assessment should be performed to identify the process parameters that should be characterized using small-scale models and tools such as design of experiments (DoE). One approach commonly used…

Article Quality by design for biotechnology products—part 3
In Part 2, published in the December 2009 issue, we addressed the use of design of experiments (DOE) to define the design space, unique considerations for process development for biopharmaceuticals, t…

Article Design of Experiments for Analytical Method Development and Validation
Design of experiments (DOE) is a well-proven characterization approach within product and process development and a key aspect of quality by design. Recently, more attention has been placed on applyin…

Article Quality by design for biotechnology products—part 2
Here, in Part 2, we address the use of design of experiments (DOE) to define the design space, unique considerations for process development for biopharmaceuticals, the establishment of a control stra…

Article Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems. By Jerold M. Martin Single-use technologies (SUT) have made significant inroads in …

Article Using Quality by Design to Develop Robust Chromatographic Methods
Quality-by-design principles can be used to understand chromatographic measurement system variability. Sep 2, 2014 By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim…

Article Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…

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