Search results for " multivariate data analysis"

Article DoE Provides Benefits, but Preparation Is Necessary
Nov 1, 2014 By: Cynthia Challener, PhD BioPharm International Volume 11, Issue 27, pp. 28-29  Using a design-of-experiment (DoE) approach allows a formulation development scientist t…

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 Improving PAT for Biologics
Software systems for multivariate data analysis (MVDA) in real-time are highly efficient tools for process monitoring and control of previously established design spaces based on current process param…

Article Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

Article Improving Upstream Predictability
Better understanding and control of cell behavior is yielding benefits, upstream and beyond. By Agnes Shanley In the earliest days of biotech, developers often struggled to sust…

Article Modeling Bioreactor Performance
He also notes that multivariate data analysis packages can transform at-line/online/near-line data into process knowledge, particularly the prediction of batch trajectories and outcomes in real time. …

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…

Article QbD Improves Cell-Culture Process Control
Using a QbD strategy that implements PAT offers the advantage of real-time process monitoring and, subsequently, quality control based on the application of multivariate data analysis and mathematical…

Article Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…

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