Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, ...
How rapid sterility testing can support a sterility assurance program. The current regulatory landscape for rapid sterility testing. Factors that impact implementation of a rapid test program. Nina ...
Aseptic processing demands reliable, robust, and validated analytical methods to ensure sterility, safety, and quality, guided by regulatory frameworks like FDA and ICH. Technological advances, ...
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