Search results for " variability" in Articles / App Notes
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Success demands consistent discipline and rigor from supply chain and manufacturing operations, as well as programs and procedures that mitigate risk and variability.
This article discusses effo…
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach
Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling.
By Elizabeth Rivera…
Article
Unifying Continuous Biomanufacturing Operations
Mechanistic modeling may be key for purification processes to be able to react to the inherent variability of cells upstream that result from perfusion, the Karst team demonstrated. Mechanistic modeli…
Article
Automating Bioprocesses
Automation of stainless-steel systems and single-use systems differs in complexity.
By Jennifer Markarian
Both upstream and downstream biopharmaceutical processes have conventionally used st…
Article
Managing Risk in Raw Material Sourcing
By Agnes Shanley
Choosing excipients and suppliers for pharmaceutical formulations requires a clear understanding of product requirements; material properties; product, process, and material varia…
Article
Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …
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…