Symcel will exhibit at the PDA Pharmaceutical Microbiology Conference 2026, taking place 25–29 October at the Westin DC Downtown in Washington, DC.
The conference brings together the global microbiology community to share practical experience, emerging approaches and regulatory insight in contamination control and modern microbiological methods.
Visit us at booth 325 to learn about the Symcel calScreener® and new caloTrace® systems for biologics and pharmaceutical sterility testing.
The systems combine growth-based detection with flexible sample volumes, automation, continuous monitoring and rapid results. All USP compendial microorganisms can be detected within 36 hours and slow growers like C. acnes within 48 hours. This enables time-to-negative results to be reduced from the 14-day compendial method to under 3 days.
Featured Presentations
This year’s programme features two presentations of particular interest for rapid sterility testing that include Symcel systems and relate to PDA Technical documents:
Technical Report No. 33: Evaluation, Validation, and Implementation of Alternative and Rapid Microbiological Methods
Points to Consider for Microbial Control in ATMP Manufacturing.
Tuesday, 27 October, 13:30–14:45, in the session Speed, Sensitivity, and Standards: Developing and Implementing Rapid Sterility for Advanced and Traditional Therapies, the following presentations will be held:
Interlaboratory Evaluation of Seven Different Sterility Testing Methods Using a Standardized Sample Set
Jason Kralj, PhD
Staff Scientist, NIST
We conducted an interlaboratory survey to assess the performance of seven sterility testing methods across 11 laboratories using a standardized sample set. The sample set included 27 blinded samples containing a CD3+ T-cell suspension matrix spiked with four compendial microbes at concentrations of 0, 10, or 100 CFU/mL, simulating low-level contamination of a CGT product. The methods tested included five viability-based platforms (BacT/ALERT, BACTEC, Celsis, calScreener+, and USP < 71>) and two molecular-based platforms (RNAseq and Microsart ATMP qPCR). This presentation will showcase the results of the different methods and highlight challenges in developing standardized materials suitable for testing various platforms.
Development of a New Rapid Biocalorimetry-Based Sterility Test to Accelerate Release Testing for CAR-T Drug Productse Set
Nore Struyf, PhD
Principal Scientist, Microbiolology SME, Johnson & Johnson Innovative Medicine
Reducing vein-to-vein time for CAR-T therapy is critical to prevent disease progression. The turnaround times of the compendial sterility method (14 days) and established rapid methods (5-7 days) are too long and faster release testing is required. Therefore, J&J IM is developing a biocalorimetry-based sterility method. This method is based on detection of metabolic heat from living organisms. Feasibility testing showed that all microorganisms guided by Ph.Eur.2.6.27 can be detected within 72 hours at low spike level. A full GMP validation study (incl. comparability) is being conducted to establish specificity, LOD, repeatability and robustness/ruggedness to support implementation of this method.
Learn more & get in touch
Read more about rapid sterility testing of biologics and pharmaceuticals.
Contact us to schedule a meeting during the event.