Welcome to this newsletter focusing on the newly launched caloTrace® system. We are excited to share the strong interest in the new platform, the new possibilities it opens for calorimetry-based applications, and the excellent results from initial customer evaluations of caloTrace sterility testing for advanced therapies.
Expanded capabilities and applications
The new capabilities introduced with the caloTrace system have been very well received, providing greater flexibility, high performance, and support for larger sample volumes. With 30 independently operated test positions, a temperature range of 20–40 °C, and sample volumes of up to 10 mL, caloTrace enables testing across diverse applications.
Whether testing for microbial contamination, drug screening, studying biofilm behavior, evaluating antimicrobial properties, or analyzing complex samples, caloTrace accelerates time to results, simplifies workflows, and enables deeper insights than traditional methods.
Webinar – Rapid microbial testing
Following the caloTrace introduction, we hosted a webinar providing an overview of its broad microbial testing capabilities.
The webinar covers the system features, biocalorimetry principles, and workflow for direct, non-destructive testing without enrichment or filtration. It also includes application data from consumer goods, food & beverage, and ingredients, with parallel testing of up to 30 samples and time to detection in as little as 8 hours.
Presentation of first caloTrace evaluation results by Johnson & Johnson
On June 24, Dr. Nore Struyf, Principal Scientist at J&J Innovative Medicine, presented caloTrace sterility testing data at A3p Association Microbiology Days in Strasbourg, France. The presentation entitled "Microcalorimetry-based sterility testing for cell therapy", included USP and EP organisms results and the journey of implementing faster sterility testing methods.
The results demonstrate the potential to dramatically reduce vein-to-vein time. Contact sterility@symcel.com to learn more about the data presented.
Publication of Symcel sterility test comparison to Pharmacopeia (USP) <71>
The recent evaluation by the Laboratory of Pharmaceutical Microbiology at Ghent University has now been published in the Journal of Pharmaceutical Innovation. The evaluation was conducted on a panel of 16 microorganisms, including both compendial strains and field isolates.
The Symcel system demonstrated excellent results with a higher number of positive samples and significantly reduced time to detection compared to the compendial method. The study concluded that it can speed up batch release without compromising patient safety.
Qualifying a caloTrace sterility system at ALS
We recently installed and qualified a caloTrace sterility testing system at ALS’s GMP-compliant testing laboratory in Sweden. ALS Scandinavia is developing a rapid sterility testing service based on the Symcel systems.
The dual-temperature setup enables parallel testing at 20–25 °C and 30–37 °C, aligned with compendial methods. Samples are directly inoculated into sterile calVials™ pre-filled with FTM and TSB media and tested in 30 + 30 independently operated channels.
Evaluation and feasability testing
The caloTrace combines rapid time-to-detection, reliable results, and flexibility across a wide range of sample types and volumes.
The platform has been evaluated in several studies, ranging from highly viscous consumer products and complex biological samples to high-concentration CAR-T therapies.
In CAR-T evaluations, we have now achieved time to detection of USP organisms in as little as 35 hours, with all key organisms detected within 2 days.
Conferences and events 🌍
Upcoming events where Symcel will participate:
- Cell & Gene Meeting on the Mesa, Phoenix, AZ, USA (5–7 October)
- PDA Pharma Microbiology Conference, Washington, DC, USA (26–28 October)
- PharmaLab Congress, Darmstat, Germany (23–25 November)
Contact us to discuss how Symcel can support your testing needs or book a meeting at these events.