The Symcel difference
The time to detection in our method is less than 60 hours in growth promotion assays of <5 CFU/ml, with C. acnes being the slowest microorganism detected at 58 hours. This is significantly faster than compendial methods (14 days) as well as todays rapid alternative microbial methods (7 days). The image to the right shows a general comparison to compendial method and blood-culture based methods, cutting time by around 60%.
Biocalorimetry, or isothermal microcalorimetry, is recognized in USP Chapter <1071> and EP Chapter 5.1.6 as a rapid phenotypic microbial test that detects the heat released during cellular metabolism. With calScreener+™ detecting even the smallest amounts of metabolic heat from living microorganisms. It objectively detects contaminations originating from a single cell (LOD < 5 CFU) even in small-volume samples.
We are currently validating our system as an alternative rapid microbial method following USP 1223, EP 5.1.6 and PDA TR33. This includes sensitivity, specificity, robustness/ruggedness and equivalency.
Take immediate action
Rapid detection of USP and select environmental organisms in growth promotion assays.
· Detect most organisms < 24 hours
· Environmental organisms < 48 hours
· C.acnes < 60 hours
Continuous measurement enabling negative-to-date measurements and automatic detection capability.
ATMP Testing
One major challenge in ATMP testing is the complexity of product matrices, which can inhibit microbial growth or mask the signal. This often requires extensive pre-processing steps, that can introduce additional variability and potentially affect the accuracy of the test results. Our biocalorimetry assay makes it possible to test directly on the product without any manipulation steps or interference from the product matrix on the signal.
Continuous measurement enables a negative-to-date risk-based approach to release testing as well as in-process testing. As the method is non-destructive, any positive sample can be recovered for further investigation and downstream processing for species ID and AST
HIGH SENSITIVITY AT LOD <5 CFU
Biocalorimetry provides a highly sensitive direct inoculation assay capable of differentiating between microbial signals and the background signal generated by eukaryotic cells and growth media. Even in samples with low initial microbial cell numbers, the assay can rapidly detect an increase in microbial metabolic activity, as exemplified by the characteristic S. aureus signal in the graph.
Our advanced machine learning algorithm, trained on a diverse dataset of microbial and background signals, can effectively identify this change in signal slope at an early stage, allowing for the confident classification of samples as contaminated.
RAPID DETECTION IN CAR-T CELL SAMPLE
Representative data of time to detection in the presence of product matrix. Experiments performed at <5 CFU in TSB and FTM growth media with direct inoculation in the presence of 10^6 cells/ml of the Jurkat CAR-T cell line. The samples were spiked with USP <71> recommended species plus C.acnes.
The time to detection is almost as fast as the growth promotion assays in absence of product, with all contaminants detected within 72 hours. Data is representative of +10 different autologous cell therapy products tested, with very fast detection regardless of product matrix.
SMALL VOLUME, NO FILTRATION, NO REAGENTS
- Only 1% of final product required for testing
- Add product and medium to vial directly
- No intermediate steps
- No sample concentration
- No filtering
- No lysing
- No dyes, no reagents
STREAMLINED WORKFLOW, OBJECTIVE READOUT
- Easy workflow
- Objective results
- Software supporting 21 CFR part 11 compliance
- Minimised risk of human error
- No special training required
Primary validation ongoing
We are performing validation studies and follow guidance for validation of alternative methods: USP <1223> and <1071>, PDA TR 33, EP 5.1.6 and EP 2.6.27. This includes sensitivity, specificity, robustness/ruggedness and equivalency. Contact us to discuss current validation results or to engage with us for early feasibility studies directly on your samples.
