Search results for " validation" in Articles / App Notes
Article
Mixing dynamics in a large volume single use mixer
Dissolution studies will be used in the future to understand the liquid-liquid and powder-liquid mixing times along with zone mapping and test validation.
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Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Lessons Learned Accelerate Vaccine Development
In addition, disposable technologies offer the potential to eliminate equipment cleaning, process cleaning validation, and cross-contamination, plus facilitate changeovers between processes, according…
Article
Continuous Processing for the Production of Biopharmaceuticals
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platf…
Article
Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
Regulatory constraints
Regulatory restrictions may exclude some cell-detachment methods from consideration in particular applications or require extensive validation before authorization of use is…
Article
Going Small to Achieve Success on the Commercial Scale
…anufacturing-related investigations, evaluation of changes in raw materials, and so on, barring only validation efforts and clinical trial/commercial manufacturing requirements for performance of lar…
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…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …
Article
The Metrics of Quality Culture
FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.
By Andrew Harrison, Susan J. Schniepp
The long awaited, anxio…
Article
Using Single-Use Technologies in Downstream Processing
According to Nilesh Mehta, senior process engineer, Merck GTO, Sterile and Validation COE, “as new technologies become available or existing technologies are converted into a single-use format, the nu…