Search results for "validation"
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Their use is central to most drug-discovery projects, from initial target validation studies, through clinical candidate selection, to subsequent translational studies (7). It is essential for drug-di…
Article
Fluid Handling in Biopharma Facilities
Disposables could represent a significant benefit in terms of facility design, validation, and investment. This trend will continue to grow as single-use systems increase a product’s speed-to-market a…
Article
Robust Optimization, Simulation, and Effective Design Space
Step Eleven: Verify the small-scale and at-scale results
Verification and validation (5) runs at the robust optimum are performed to verify the model prediction and the actual measurements are…
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…
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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
…equipment or material
• Change in test method or documentation
• Re-qualification or re-validation of a test method.
Material Distributor or Warehousing
• Use of a new facility for st…
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…