EVALUATION PRESENTED AT THE 2025 EUROPEAN MICROBIOLOGICAL CONFERENCE IN VIENNA
The presentation — delivered by Nathalie Vendur — highlighted data on the impact of stressed organisms, an evaluation of media vendors, and the effect of limit of detection (LOD) on time to detection, with particular focus on the rate-limiting organism C. acnes. Studies were conducted on calScreener+ Sterlity system both in the presence and absence of product, including 10⁶ eukaryotic cells and a range of monoclonal antibodies (Fig 1.)
Figure 1. Main focus areas of Roche proof-of-concept evaluation. Image courtesy of Roche.
SUMMARY OF EVALUATION RESULTS
Evaluation results of the microbiological technique based on microcalorimetry are summarized in Fig. 2. The findings show that growth media from different suppliers can significantly affect time-to-detection (TTD), underlining the importance of standardization. Even under varying conditions, such as heat exposure or the presence of mAbs and eukaryotic cells, detection occurred within 3–4 days, demonstrating a robust and accelerated sterility testing process.
Figure 2. Evaluation results of calScreener microcalorimeter system. Image courtesy of Roche.
CONCLUSION & OUTLOOK
The time to results was reduced by more than 70% compared to compendial sterility methods, with consistent detection across a broad range of microorganisms. These findings led to the conclusion: “CalScreener+ is a groundbreaking technology, especially for cell and gene therapy.” (Fig. 3)
Figure 3. Study conclusion. Image courtesy of Roche.
Results confirmed that microcalorimetry brings speed, precision, and reliability to sterility testing in biologics and cell and gene therapy production. Considerations to take into account when validating the system for implementation were growth-media composition, sample characteristics, and temperature stability in the testing environment.
Learn more about sterility testing of cell & gene therapies with calscreener+.