Search results for " design" in Articles / App Notes
Article
Defining Risk Assessment of Aseptic Processes
This is accomplished through proper building, equipment materials, and design; established and validated cleaning procedures; proper training for personnel; and continuous monitoring of the personnel …
Article
Real Time Continuous Microbiological Monitoring
By Claudio Denoya
Nonviable particulate and viable microbiological surveillance are used to evaluate the design and control of a current good manufacturing practice (cGMP)-manufacturing environmen…
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High-Throughput Process Development Handbook
This allows a large experimental space to be characterized and supports the definition of a well-established process design space where process parameters that need to be monitored and controlled are …
Article
Mixing dynamics in a large volume single use mixer
Dispersion and settling were evaluated as part of this study, which provides a clear decision path on the tank shape and impeller quantity for a given impeller design and a given impeller location. D…
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Innovation vs. Capacity: How CMOs Compete
But none of these designations reflect the strategies that each CMO is pursuing, and without that basic understanding, one cannot fully understand the prospects for the industry.
In PharmSource’s …
Article
Process Chromatography Selection for Downstream Processing Applications
Important factors such as column design, resin development, and automation have all played a role in simplifying the purification process, in some cases reducing it from five steps to three (1). Selec…
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Innovative Therapies Require Modern Manufacturing Systems
… States; and CDER continues to receive hundreds of requests from manufacturers for breakthrough drug designations, a program that has led to the approval of more than 20 innovative products (2).
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GMP Challenges for Advanced Therapy Medicinal Products
As a result, it has been designing training course packages aimed at specific target groups, such as cell biology scientists who know about ATMPs but need to learn GMP skills.
The project, whose pa…
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A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
… the impact of the production sources considered for the process, and the economic aspects of all we design and do in a bioprocess. We think it is smart to be on top of the links between all parts of…
Article
Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
…tegories of the research and publication process: biological reagents and reference materials, study design, laboratory protocols, and data analysis and reporting (3). Although each contributes to a …