Search results for " multidimensional"
Article
Use of Multivariate Data Analysis in Bioprocessing
All these applications involve reduction in multidimensionality of these datasets to a lower number of uncorrelated variables that can explain most of the variance obtained in the original data. They …
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
Determining Criticality, Part Two: DoE and Data-Driven Criticality
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle.
T…
Article
Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
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
Addressing the Challenges in Downstream Processing Today and Tomorrow
The concept of a design space has been introduced, which is defined as the multidimensional combination and interaction of input variables and process parameters that have been shown to provide assura…
Article
Quality by design for biotechnology products—part 1
Per ICH Q8(R2), the design space is
the multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide as…