Search results for " method"
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Real Time Continuous Microbiological Monitoring
Therefore, these microorganisms, known as viable but not culturable (VBNC), are not detected using the traditional methodology. In addition, traditional methods are unable to sample every particular l…
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Process Chromatography Selection for Downstream Processing Applications
In order to address bioburden, one needs good sanitization methods and knowledge about likely species present in the local environment. Techniques such as closed column packing and/or the use of pre-s…
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Selecting a Comprehensive Bioburden Reduction Plan
…nitization requirements, establishment of alert/action levels, selection of monitoring and detection methods, operator training requirements, and quality system oversight.
BioPharm: What procedur…
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Continuous Manufacturing: A Changing Processing Paradigm
If overall bioprocess yields continue to double every five years, switching from batch bioprocessing to continuous methods may prove even more difficult (1). Making the switch, says Snow, will require…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Materials and Methods
Resins, films, and standards of TBPP used in the study were kindly provided by Renolit, in Enkhuizen, The Netherlands. This included Solmed Infuflex 9101 resin and film (deno…
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Improving PAT for Biologics
Advances in high-throughput systems, Raman and near-infrared (NIR) spectroscopy, high-performance single-use sensors, and chemometric methods are also helping manufacturers of biopharmaceuticals overc…
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Essentials in Establishing and Using Design Space
Misconception One: Design of experiments is the same as design space
Design of experiments (DOE) is not the only method for determining a design space. Other methods can be used including know…
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Essentials in Quality Risk Management
…g drug development and manufacturing and changes in drug-product formulation, definition, analytical method, and associated process changes are understood and managed to ensure patient safety and dru…
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Genetic Vaccine Platforms Demonstrate Their Potential
“This decreased level of process and method development results in a substantial reduction in cost, and more importantly during a pandemic, the time from determination of identity and sequence of the …
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Mapping a Route for Cell and Gene Therapy Process Development
These products are highly complex and often involve production methods that, while in some ways are similar to those used in biologics and vaccine manufacturing, in many ways are quite different.
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