PDA Midwest: Rapid Micro Methods for ATMPs and Other Biologics
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PDA Midwest and Southeast Chapters invite you to learn about four specific Rapid Microbiological Methods available in the biologics space, with the help and background of an industry panel of experts!
The term ATMP includes short-shelf-life drugs and therapies with a biologically-sourced Active Pharmaceutical Ingredient (API) that is either a recombinant nucleic acid or cells. These include stem cells, CAR-T cells, gene therapies, mRNA therapies, and more. This CUTTING -EDGE research may hold the keys to curing cancers, neurological disorders, birth defects, orphan diseases, and yes, even a Pandemic.
The emergence of these REVOLUTIONARY therapies comes with a significant challenge: ensuring they are free of contamination as quickly as possible due to their short shelf lives. As they are often administered within hours of preparation, there is a significant patient safety risk to using traditional methods relying on 14 or more days of incubation of used to test for sterility and up to a week for bioburden results.
Rapid microbiological methods (RMMs) provide a viable solution for this challenge by detecting contamination sooner and reducing patient safety risks.
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Day 1
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