Search results for " experimental design"
Article
Determining Criticality, Part Two: DoE and Data-Driven Criticality
Including replicate runs in addition to the study experimental design provides crucial data for estimating the underlying variability of the study. This is because, during each run, small unmeasured a…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
By applying a continuum rather than a binary method to criticality throughout the lifecycle, we can set priorities to focus time and resources in areas of greatest impact to quality including experime…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
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.
A…
Article
DoE Provides Benefits, but Preparation Is Necessary
Nguyen also notes that depending on the data that are generated from an experimental design, it is sometimes possible to gain some mechanistic understanding of protein stabilization or behavior.
I…
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…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Even with high-throughput miniature bioreactors and efficient experimental design, however, it is still not feasible to characterize the effects of 170 factors.
One approach…
Article
Breakthrough Drugs Raise Development and Production Challenges
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
Jul 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 7, pg 8–9
The FDA pro…
Article
Addressing the Complex Nature of Downstream Processing with QbD
Quality by design brings both challenges and benefits to the development of downstream processes.
By Susan Haigney
natali_mis/Stock.Adobe.com
Regulators have been en…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
Screening experimental designs with these components at low and high ranges of concentration is helpful for determining which components have important effects on productivity and quality (9). Design-…
Article
Using Multiple Techniques in Biosimilar Analysis
It also illustrates that exploring orthogonal techniques, and indeed, letting them ‘compete’ with one another, can enhance experimental design, especially for products challenging the resilience of a …