Sterility testing is crucial for Advanced Therapy Medicinal Products (ATMPs) such as cell therapies, as microbial contamination can be fatal for treatment recipients. The time to result is a significant factor to consider when choosing an assay for sterility testing. Conventional tests require 14 days to rule out most microbial contaminations, but for cell-based therapeutics with a short shelf-life, there is a growing demand for fast, growth-independent tests. A highly sensitive and broad range microbial detection system for DNA isolation and real-time PCR helps scientists rapidly detect bacterial and fungal contamination, ensuring ATMP sterility.
Download this application note to learn how the Microsart® ATMP Sterile Release kit combines efficiency in sample preparation and reliability in bacterial and fungal DNA detection, demonstrating advantages over alternative methods.
