Search results for " validation" in Articles / App Notes
Article
Applying GMPs in Stages of Development
Areas to be reviewed to determine the appropriate level of control needed in concert with the phase development stage include: level of validation of test methods, level of detail needed in batch reco…
Article
Navigating Data Integrity in the Modern Lab
While validation is still necessary, this removes both the day-to-day complexity in the lab and much of the risk of compromised data integrity.
PharmTech: How can manipulation of electron…
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Industry Adoption of Single-Use Systems Remains Low
In addition, equipment validation is required before re-use (4).
To put the time consideration into perspective, a typical clean-in-place cycle for vessels between 100 L to 1000 L can run…
Article
Bioburden Control in the Biopharmaceutical Industry
Clontz, Microbial Limit and Bioburden Tests: Validation Approaches and Global Requirements, (CRC press Taylor & Francis, Boca Raton, FL, 2nd ed., 2009).
2. A.M. Cundell, “Comparison of Microbiol…
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Mechanistic Modeling of Preparative Ion-Exchange Chromatography
Development of a mechanistic model requires three major steps: modeling of mass transfer, modeling of binding, and finally, validation of the mechanistic model. The choice of details depends on the de…
Article
Single-use Bioreactors Have Reached the Big Time
Film validation using harmonized methods will, in the future, establish a framework for comparison and validation of product contact films for a process, reducing time and effort for the user, notes O…
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Technical and Process Economical Aspects of Using Capto™ Q and ReadyToProcess™Adsorber Q in mAb Polishing
… cleaning and storage, as well as process time, for example, by minimizing the need for cleaning and validation operations and by allowing for higher flow rates.
While sometimes perceived as cost…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
A similar pattern plays out in validation services. This is also a growing area of opportunity for CMOs, with validation services a more popular outsourcing activity than process development. In the 2…
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Late-stage development starts with set up and validation of analytical methods and with securing reagents (8–10) for the analytical program. A broad range (50–60 variants) of different analytical tech…
Article
Breakthrough Drugs Raise Development and Production Challenges
Manufacturers need to decide dosage form and methods validation strategies much sooner, he said at the CMC workshop, and should “plan for the unexpected,” such as facility qualification failures and c…