Rapid sterility testing

SHORTENING THE RELEASE TIME OF CELL AND GENE THERAPIES AND BIOLOGICS

Detection in hours, results in 2–3 days
Continuous phenotypic monitoring
Direct inoculation of product
Non-destructive measurement
Flexible test volumes

Advanced therapies and biologics need to be available to the patient quickly, and today’s post-manufacture release times are too slow. The long turnaround times and complex procedures of traditional sterility tests lead to long vein-to-vein times, high development costs, and increased patient risks.

The Symcel calScreener+ and caloTrace Sterility Testing Systems are designed specifically to address these challenges. They provide reliable growth-based detection within hours, including C. acnes in as little as 48 hours, and negative results in as little as 2–3 days. The systems combine high sensitivity (target LOD 1 CFU), continuous real-time monitoring, and straightforward workflows with minimal sample preparation.

Welcome to next-generation sterility testing.

RAPID STERILITY TESTING OF CELL AND GENE THERAPIES

Isothermal microcalorimetry detects heat with extreme sensitivity. We have optimized a microcalorimeter specifically for the easy, accurate, and fast detection of metabolically active organisms.

Time to results is less than 60 hours in growth promotion assays of <5 CFU/mL, with C. acnes being the slowest microorganism detected in as little as 48 - 58 hours. This is significantly faster than compendial methods (14 days), as well as other rapid-growth microbial methods (7 days). The image to the right shows a general comparison to compendial methods and colorimetric blood culture-based methods, cutting time by around 60% while minimizing the risk of false results.

This means faster results no longer require compromising on safety or reliability, and allows you to overcome challenges associated with testing complex product matrices, simplify manufacturing processes, and slash your time to market.

rapid microbial detection

Release times are critical for life-saving therapies. Our novel biocalorimetry technology delivers faster, continuous, and more actionable results. With accurate, decisive results available in less than three days, product release decisions can be made earlier and with full confidence.

Majority of bacteria detected in < 24 hours
Fungi, including A.brasiliensis, in < 48 hours
C. acnes, assay rate limiting organism, detected in < 60 hours

Minimized risk of false results, even in complex backgrounds

The calScreener+ and caloTrace growth-based systems measure continuously and, since they work phenotypically, detect only viable microorganisms. They offer exceptional sensitivity, with a limit of detection (LOD) down to 1 CFU, and minimise the risk of false results caused by debris, residual genetic material, or components of the cellular product.

Where other growth-based sterility methods rely on a chain of indirect measurements, the isothermal microcalorimetry-based systems offer a more direct measure of microbial activity.

STERILITY TESTING OF COMPLEX CELL THERAPY PRODUCT MATRICES

One major challenge in testing Advanced Therapy Medicinal Products (ATMPs) is the complexity of their product matrices, which can inhibit microbial growth or mask detection signals. This often requires extensive pre-processing steps that can introduce additional variability and potentially affect the accuracy of the test results. Biocalorimetry enables direct inoculation and reliable detection of contamination—even in highly complex sample matrices. This makes the Symcel sterility test optimal for cell and gene therapy products.

No filtering
No sample concentration
No extraction

EASIER CONTAMINATION INVESTIGATION

Root cause analysis is critical if contamination is detected. The calScreener+ and caloTrace measurements are non-destructive and require no sample manipulation steps or interfering reagents. If a sample is found positive, inoculated samples can immediately be analyzed further using standard methods.

No reagents
No dyes
No lysing

PRESERVE MORE PRODUCT FOR THE PATIENT

Traditional sterility testing methods require sample volumes that many advanced therapy products simply can’t spare. In contrast, the Symcel systems require only a minimal volume, enabling reliable testing even when product availability is critically low.

caloTrace sterility feasability testing_2

3-DAY CAR-T THERAPY STERILITY TESTING

Case study using a Jurkat CAR-T cell line. Study performed at <5 CFU in TSB and FTM growth media with direct inoculation in the presence of 10⁶ CAR-T cells/ml. The samples were spiked with USP <71> recommended species plus C. acnes.

Data is representative of more than 10 different autologous cell therapy products tested, with fast and accurate detection, regardless of the product matrix.

Symcel sterility testing time to detection

Strategic R&D collaboration with Johnson & Johnson

Sterility testing is the most time-consuming step in releasing cell therapies. Current methods can take 7–14 days, delaying access to critical treatments. This collaboration aims to deliver a validated, GMP-compliant test that cuts release time to under 3 days—improving manufacturing efficiency with faster access for patients.

CALSCREENER⁺STERILITY

Feasibility to routine testing

Based on the calScreener® platform, the calScreener+ Sterility Testing System is a compact benchtop platform with dual-temperature measurements, performing tests directly in vials containing the growth medium, with no need for preparatory steps or the addition of costly reagents. The system supports parallel testing of up to 32 samples at each temperature.

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CALOTRACE STERILITY

Scaling to automation

The caloTrace® Sterility Testing System extends the benefits of isothermal microcalorimetry to larger sample volumes and features 30 independently loaded positions per temperature. It is developed for routine sterility testing and QC environments, combining continuous monitoring, growth-based detection, and direct inoculation in prefilled FTM and TSB calVials™.

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VALIDATION & REGULATORY

The Symcel Rapid Microbial Method (RMM) systems follow the US and EU standards USP <1223> and <1071>, PDA TR 33, EP 5.1.6 and EP 2.6.27. Primary validation package is conducted on method limit of detection (LOD), comparability, specificity, ruggedness and robustness, with data package availability before conducting method validation. Measurement performance of calScreener+ compared to the compendial USP <71> sterility test has been evaluated on a broad panel of microorganisms.

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