Advanced therapy medicinal products (ATMPs) require stringent sterility testing. Traditional growth-based methods can take up to 14 days to deliver results, posing a significant challenge for cell therapies with short shelf-lives and patients awaiting treatment.
PCR-based rapid sterility testing offers a groundbreaking alternative, providing accurate contamination detection within hours while maintaining the sensitivity required to ensure patient safety.
This application note details an in-depth study comparing two PCR-based release kits, assessing both sensitivity and workflow efficiency for ATMP quality control laboratories.
This application note details an in-depth study comparing two PCR-based release kits, assessing both sensitivity and workflow efficiency for ATMP quality control laboratories.
Download this application note to find out.
- How PCR-based rapid sterility testing significantly reduces the time to results from 14 days to just hours.
- Solutions for detecting bacterial and fungal contamination using PCR-based sterility testing.
- Key considerations for integrating rapid sterility testing into your ATMP quality control processes.
Read Application Note: Benchmarking of Two Real-Time PCR-Based Rapid Sterility Testing Kits
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