Search results for " analyses"
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
In HTPD, simple absorbance measures such as A280 measurements can be used, and additional analyses carried out for the most critical conditions. In this mAb case study, SBC increased by increasing pH …
Article
Biopharma Advances Demand Specialized Expertise
…roism (CD) and fourier transform infrared spectroscopy (FTIR) for higher-order structure as critical analyses to understand and compare and detect subtle higher-order structural differences between i…
Article
Continued Process Verification for Biopharma Manufacturing
Data and analyses provided by CPV should be used to meet APR requirements, eliminating redundancy between these GMP systems.
CPV and Quality by Design
Quality by design (QbD) means scientifica…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Based on the data analyses from DoE-1, the three parameters that had the largest collective impact on both resolution and limit of quantitation (LOQ) were the gradient change time, the column temperat…
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Challenges of Protein Aggregation During Purification
Use of such real-time process analytical techniques for the monitoring and control of product aggregation will need to be justified, however, with the completion of appropriate cost/benefit analyses,”…
Article
Evaluating Design Margin, Edge of Failure and Process
Two additional analyses are required to assure the chemistry, manufacturing, and control (CMC) team and associated health authorities all set points are safe with low out-of-specification (OOS) rates …
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Improvements must be made in the way risk assessment and analyses are performed and documented.
SUMMARY
The recent surge in the number of enforcement actions suggests that the current state of…
Article
Advancing QbD in the EU
In the longer term, the agency is considering making some QbD elements mandatory rather than optional by requiring submissions by all marketing authorization holders of risk analyses of their manufact…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…