Rapid Sterility Testing for Cell and Gene Therapy: Accelerating Progress with Isothermal Microcalorimetry

Nowadays we’re venturing into a pivotal domain that is transforming the landscape of cell and gene therapy: rapid sterility testing. All forward-thinkers are well aware, sterility testing is anything but mundane. In the cell and gene therapy field we are looking for technologies that can do the job, reliably and fast. Biocalorimetry is a game changer, and here’s why.

Before elaborating more into the ‘rapid’ aspect, let’s revisit sterility testing itself. In cell and gene therapy, sterility is key. Sterility testing, a critical procedure checking for any harmful microorganisms in cell and gene therapy products, ensures these therapies are safe and free from contamination before reaching patients.

The Drawbacks of Traditional Sterility Testing
Traditional sterility testing methods, while they’ve served us well, are frankly painfully slow. The process of incubating samples for up to 14 days to allow potential microorganisms to grow and become detectable can be very frustratingly. Additionally, these methods often require large volumes of the sample, which may be destroyed or lost after analysis. In an era where time and efficiency are of the essence, a change is needed.

The Advent of Rapid Sterility Testing
Enter the world of rapid sterility testing, a promising field laden with innovative solutions designed to expedite results. Among these are PCR (Polymerase Chain Reaction) and NGS (Next-Generation Sequencing), technologies that have redefined our approach to microbial detection.

PCR amplifies specific DNA or RNA sequences from microorganisms, making them easily detectable, while NGS analyzes the genetic makeup of microorganisms within a sample. However, these methods come with their own limitations. PCR may miss certain organisms due to a lack of specific primers as well as background interference, and NGS can be expensive and time-consuming to set up.

The Rise of Isothermal Microcalorimetry: Introducing the calScreener™
At the forefront of this evolution is Symcel’s calScreener™, an isothermal microcalorimetry instrument that addresses these pitfalls. The calScreener™ incubates while continuously monitoring for metabolic signals from contaminants, effectively reducing time and enhancing accuracy. With detection limits lower than ever, it slashes the standard 14-day wait to just 3 days—an impressive 80% reduction in time!

The calScreener™ also has the bality to handle small volumes which preserves the integrity of the batch and enables testing directly on the final product. Moreover, its capacity to differentiate mammalian background signals makes it ideal for patient-derived samples or cell therapies such as CAR-T.

Evidence of Efficacy: A. brasiliensis Spores and Cutibacterium acnes
The calScreener™’s efficacy is backed by its successful detection of slow-growing organisms such as A. brasiliensis spores and Cutibacterium acnes. The rapid detection of these organisms underscores the transformative impact of isothermal microcalorimetry on sterility testing.

Symcel’s Commitment to Progress
Symcel’s dedication to constantly improving biocalorimetry technology is central to everything we do. In collaboration with leading authorities in the field, we are committed to delivering the fastest and most reliable results, leading sterility testing into a new era.

Rapid sterility testing, particularly with the calScreener™, is revolutionizing the cell and gene therapy fields. Offering quicker, more reliable results, this innovation not only saves precious time but also heightens patient safety and broadens access to life-changing treatments. As we embrace this scientific evolution, the future of rapid sterility testing looks bright, making the world of cell and gene therapy even more compelling.