Search results for "doe" in Articles / App Notes
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
The first category, empirical modeling, is where the model is built using experimental data based on approaches such as the design of experiments (DOE). The second category is mechanistic modeling, wh…
Article
Platform Approach Speeds Process Development
The platform includes vector design, cell line engineering, high-throughput screening by automation, systematic design of experiment (DoE)-based approaches for media and cell-culture process developme…
Article
Going Small to Achieve Success on the Commercial Scale
Because they are models, however, such a situation does not occur. The goal, therefore, is to mimic the commercial-scale process as closely as possible.
The impact of QbD and DoE
The quality-b…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
This has enabled design of experiment (DoE) approaches, such as response surface optimization, to be used. Second, better systems for collecting, storing, and analyzing process data have facilitated t…
Article
Improving PAT for Biologics
Finally, implementation of PAT for bioprocesses implies the extensive use of the design-of-experiment (DoE) approach. “The cost for DoEs in the biopharmaceutical industry can be quite high, and DoEs c…
Article
Biopharma Outsourcing Activities Update
On the other end of the spectrum, design of experiments (DoE) (34.1%), downstream process development (36.3%), and quality-by-design (QbD) services (37.4%) are the least likely to be outsourced, altho…
Article
Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
In Part II, the preliminary risk levels of process parameters provided the basis of characterization studies based on design of experiments (DOE). Data from these studies were used to confirm the cont…
Article
A Platform Approach for the Purification of Domain Antibodies (Dabs)
All purification steps were optimized by Design of Experiments (DoE), thereby supporting a Quality by Design (QbD) approach.
Using Capto L, Capto MMC ImpRes, and Capto adhere ImpRes media in …
Article
Essentials in Quality Risk Management
…ess capability
•Control charts
•Sniper plots
•ANOVA and hypothesis testing
•DOE (product and process)
•Variation studies, partition of variation (POV), and residual expected maxim…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
What it does demonstrate, however, is that using the aforementioned QbD model, the CMO portion of the product commercialization is unlikely to ever be the bottleneck for a commercialization timeline. …