Search results for " variability"
Article
Improving Process-Scale Chromatography
She adds that Cytiva’s IC skid requires less space than ILD and also addresses issues with buffer variability by allowing for feedback control of the buffer preparation process. “Dynamic control caref…
Article
A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
NIR coupled with chemometric analysis was used for the characterization of soy raw material to evaluate the variability and impact on product quality. The analysis revealed that near-infrared spectra …
Article
Going Small to Achieve Success on the Commercial Scale
Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.
By Cynthia A. Challener
Biopharmaceutical manufacturing involves a series o…
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
Use of a subspace model is a viable method to characterize process space variables and optimize process performance.
By Colin Jaques, Daniela Lega
Over the past decade, two improved capabili…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Figure 1: Graphic showing IgG antibody structure, sites for glycosylation, and potential variability.
Proteins are delicate molecules compared with small-molecule drugs and present multiple stabili…
Article
Best Practices in Qualification of Single-Use Systems
The alignment of criteria should include any variability in appearance, such as minor blemishes on the exterior of SUS arising from transport and handling, which do not impair the function of the asse…
Article
Robust Optimization, Simulation, and Effective Design Space
…s could follow a sequence such as the one shown below:
• Identify potential sources of process variability.
• Identify the material attributes and process parameters likely to have the greate…
Article
DoE Provides Benefits, but Preparation Is Necessary
“While a formulation scientist needs to know where the most stable space for an API resides, an analytical chemist may be more interested in the variability and reproducibility of results, both of whi…
Article
Applying GMPs to the BioPharma Supply Chain
Elimination and control of sources of variation
Suppliers need to understand how variability in the manufacturing process affects the quality attributes of their product. They need to have tools t…
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiment is a powerful development tool for method characterization and method validation.
Design of experiments (DOE) is a well-proven characterization approach within product…