Search results for " validation" in Articles / App Notes
Article
Biopharma Advances Demand Specialized Expertise
Integrating risk-based review, GMP inspection, implementation of quality by design, and the new FDA process validation guidance within one office is expected to significantly change the biopharmaceuti…
Article
Re-use of Protein A Resin: Fouling and Economics
Sofer, “Lifespan studies for chromatography and filtration media” in Process Validation, A. S. Rathore and G. Sofer, Eds. (Marcel Dekker, 2005), pp. 169-203.
20. A. S. Rathore, “Qualification of a…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
The ATP criteria, as with ICH method validation criteria, are established based on considerations for patient safety and product quality and are consistent with the capability of analytical methodolog…
Article
Evaluating Design Margin, Edge of Failure and Process
Measures of process capability may be determined during development and confirmed during confirmation batch runs and formal process validation (5).
Cpk is a Poor Measure of Capability
Cpk has …
Article
Biopharma Moves to Integrated, Single-Use, Downstream Processing
“These concerns have, however, been successfully addressed by single-use suppliers through validation studies,” he stresses.
Drivers for adoption
The success that biopharmaceutical manufacture…
Article
Supplier-Change Management for Drug-Product Manufacturers
These deliverables may include, but are not limited to:
• Receipt of additional information from the supplier
• Execution of qualification studies or review of supplier validation summaries
…
Article
Overview of a scale-up of a cell-based influenza virus production process using ReadyToProcess equipment
Furthermore, disposables minimize the risk for cross-contamination between production batches, and the need for time-consuming and costly cleaning and validation procedures is made redundant.
Si…
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Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
…specially for smaller companies in the early stages of development at smaller scales, where cleaning validation is not a top priority,” he explains.
Hold-up volumes also become increasingly import…
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Virus safety challenges: get the job done!
Virus safety is key in bioprocessing. In this free 1-day seminar you’ll learn how to conduct virus filterability trials, including prefiltration.
Click here for more information
Article
Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems
In a validated GMP process, filters must be routinely tested for integrity. The automated test instruments that are used for filter integrity testing have been improved over the past 40 years. …