Search results for "design of experiments"
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Handbook: Design of Experiments in Protein Production and Purification
Design of experiments (DoE) is a technique for planning experiments and analyzing the information obtained. The technique allows us to use a minimum number of experiments, in which we systematically v…
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…
Article
Increase Efficiency in Experimentation with Design of Experiments
Learn more about how to benefit from DoE study setups from the handbook Design of Experiments in Protein Production and Purification.
Article
Increase Efficiency in Experimentation with Design of Experiments
Setting up an efficient study can help you save time and allow you to get the most out of screening and optimization experiments during method development. Also, good planning and relevant experimen…
Article
How to program, run and evaluate a design of experiments (DoE)
You’ll learn how to program, run, and evaluate a design of experiments (DoE) run. An application example showcases how to optimize an antibody purification for low dimer-and-aggregate and host cell pr…
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Design space and design of experiments
The goal is to increase process knowledge by providing a mechanistic understanding of the relationship between process parameters, raw material attributes,…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
In Part II, the preliminary risk levels of process parameters provided the basis of characterization studies based on design of experiments. Data from these studies were used to confirm the continuum …
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
Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…