At PDA's Annual Meeting in the United States, and at ECA's Annual Pharma Congress in Germany, Spore.Bio officially launched TMSI, the world's first reagent-free, culture-free microbiology platform capable of detecting, quantifying, and identifying living microorganisms in under 10 minutes.
The launch was coupled with the publication of a scientific white paper describing initial validation data for bioburden testing, including Accuracy, Limit of Quantitation and Linearity, using the statistical analysis recommendations expected to be published in the upcoming revision to PDA Technical report #33.. Additionally, the studies investigated how the Louis System differentiates live cells from dead cells, how the system can be used for microbial identification and a multiplexing platform for reporting both total aerobic microbial count and total yeast and mold counts in non sterile pharmaceutical dosage forms. The white papers were published in American Pharmaceutical Review and European Pharmaceutical Review.
The Spore.Bio Louis System employs a transformer-based multimodal spectral imaging (TMSI) approach, integrating biophotonic hardware with artificial intelligence (AI)-based, deep machine learning models for microorganism detection. The technology collects viable organism signals in the visible, UV and near-infrared wavelengths. These signals are gathered as unique spectral fingerprints of the organisms at the single-cell level, which are fed into the models that were trained on thousands of real-world samples, representing millions of images. The end result is a rapid technology that operates without growth enrichment or labelling requirements, demonstrates compatibility across diverse sample matrices and enables simultaneous detection, quantitation and species-level identification within a unified analytical platform.
The TMSI technology combines spectroscopic and spatial information to achieve single-cell resolution (400nm). The multispectral approach captures signals across six wavelengths under dual illumination at 405nm and 365nm, enabling the collection of both absorption data and intrinsic fluorescence from metabolic molecules such as NADH, flavins and porphyrin.
The combination of these molecular signatures, coupled with their spatial localisation within cells (eg, a signal stronger at the centre versus a diffuse signal within the cell), morphological aspect (eg, thickness of the membrane and shape of the organism) and their cumulative and relative fluorescence excitation intensities, generates a unique spectral signature that enables differentiation of microorganisms from inert particles or sample matrix components, alongside microbial identification at the species level.
The company's future deliverables include performing a comprehensive primary validation and the assessment of a broader selection of strains, including Viable But Non-Culturable (VBNC) and stressed cells. Additionally, comparability will be demonstrated for bioburden and sterility testing across multiple pharmaceutical dosage forms, including filtrable and non-filtrable substances, such as powders, vaccines, small and large molecules.