Stockholm, Sweden, 2026-06-23 – Symcel announces the initiation of customer evaluation studies for the caloTrace® Sterility Testing System, a next-generation platform for rapid microbial testing of cell and gene therapies, biologics, pharmaceuticals, and other sterile healthcare products.
The program enables pharmaceutical and advanced therapy developers to evaluate the platform on their products and in-process samples, ensuring robust performance while optimizing workflows, data management, and system integration to meet their specific requirements.
The manual caloTrace, including primary validation package, is targeted for launch in November 2026. Deliveries of the automated sample handling upgrade is expected to begin in the first half of 2027.
Addressing the need for faster yet reliable sterility testing
Release times are critical for life-saving therapies, and sterility testing is currently a key bottleneck, delaying patient access and increasing manufacturing costs. The caloTrace® Sterility testing system is based on highly sensitive isothermal microcalorimetry and is designed to address this problem. It combines rapid results, continuous monitoring and growth-based detection minimizing the risk of false-positive results from non-viable cells. The platform features 30 independently loaded random-access channels per temperature and supports direct, non-destructive testing in 13 mL vials, enabling larger and more representative sample volumes to be analyzed.
"Slow-growing organisms have traditionally been one of the greatest challenges in rapid sterility testing," says Dr. Wilhelm Paulander, Chief Clinical Development Officer at Symcel. "The combination of high sensitivity heat detection and continuous real-time monitoring enables many microorganisms to be detected within just a few hours. The ability to detect organisms such as C. acnes in as little as 48 hours demonstrates the potential to achieve time-to-negative sterility testing in 2-3 days.
Regulatory alignment
The caloTrace Sterility System is being developed to support implementation in GMP-regulated environments including primary validation package to support method specific validation. Using prefilled sterile calVials containing compendial FTM and TSB media, the platform supports dual-temperature testing at 20–25 °C and 30–37 °C in alignment with compendial sterility testing practices.
The system is being developed with a target limit of detection of one colony-forming unit (CFU), consistent with expectations for alternative microbiological methods outlined in USP <1223>. The calView® software is available with a 21 CFR Part 11 compliance package, and IQ/OQ/PQ documentation support system qualification.
Collaboration with industry leaders
Testing and developing the system in collaboration with leading pharmaceutical and advanced therapy developers helps ensure that the platform aligns with user requirements, validation expectations, and the requirements of regulated manufacturing environments.
"The start of these customer evaluations marks an important milestone for the caloTrace Sterility Testing System" says Dr. Jesper Ericsson, CEO of Symcel. "We have already run the first customer samples with excellent results. Working directly with industry leaders allows us to demonstrate the value of the technology in real manufacturing environments while gaining valuable insights that help shape future development."
From method development to automated testing
The caloTrace Sterility Testing System is being developed in both manual and automated configurations. The automated workflow combines automatic vial identification, loading, and monitoring with full sample traceability through unique vial IDs, batch numbers, and data matrix codes. The core system stays the same, so biological validation can be performed on the manual version ahead of potentially upgrading to the automated sample handling module. Complemented by the benchtop calScreener® sterility system, the caloTrace platform offers a scalable path from method development to routine quality control testing.
Expanding applications across the pharmaceutical industry
The caloTrace® platform is being developed to support a broad range of pharmaceutical applications. Its ability to directly analyze complex sample matrices makes it particularly well suited for biologics, cell cultures, and other challenging products where matrix interference can limit the performance of conventional methods. As part of a grant awarded by the Coalition for Epidemic Preparedness Innovations (CEPI), Symcel is developing a vaccine test method aimed at enabling sterility testing in under three days.
About Symcel
Symcel is leading a new era in metabolic measurements for microbial testing, biological research, and diagnostics. The company's biocalorimetry platforms provide a novel approach to detecting and analyzing biological activity using isothermal microcalorimetry, with applications ranging from sterility testing of advanced therapies and microbial detection in foods and consumer goods to biofilm, microbiome, and cell research. Founded by leading authorities in microcalorimetry, Symcel is headquartered at the Karolinska Institute in Stockholm, Sweden. Learn more at symcel.com.
Media contact:
Per Lidén, Marketing Manager
per.liden@symcel.com