ParticleSentry is the first software platform offering AI-based, particle image analysis with outlier detection for biopharmaceutical development and manufacturing. The software is based upon five years of testing and development and represents a substantial leap forward in tools available to scientists and engineers for candidate screening and process development. The software recognizes patterns, textural and morphological features that are difficult or impossible for humans to discern and leverage. The analysis allows for creation of a fingerprint that represents the typical heterogenic population of particles in a sample. The fingerprint can be used for quick and easy comparison during candidate testing, like excipient/surfactant screening, stability and stress testing, interface testing, timed storage testing and container/closure and interface testing and qualification.
“AI image analysis is everywhere today – from airports to banking and other identity-critical applications. In the pharmaceutical industry we are already seeing applications in visible particle and packaging inspection gaining market acceptance. ParticleSentryᴬᴵ is the only software platform delivering focused, tested and versatile AI in the biologics formulation development space. It will eliminate the subjective human analysis of particles from various imaging platforms. Our unique machine learning approach leverages computational statistics to analyze the morphological features contained in the images – not simply the features we as humans can easily discern. So far, in the biologics formulation development space, machine learning approaches have employed supervised learning and confusion matrices to evaluate image data. These simple methods don’t deliver critical information on new statistically relevant particles or aggregates – the ones you haven’t anticipated or seen previously. Our solution delivers these easy-to-understand confusion matrices and goes further to help identify new particles or aggregates of statistical concern. Scientists and engineers from candidate selection, formulation development and process development will find ParticleSentryᴬᴵ provides answers to questions they didn’t know they had!”, said Glenn Brandon, CEO of SentrySciences.
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In 2019, SentrySciences acquired an exclusive license to commercialize an AI patent for application in the pharmaceutical space. Using a convolutional neural network (CNN) and computational statistics, ParticleSentryᴬᴵ analyzes images produced by various microscopy platforms and creates a ‘fingerprint’ of the subvisible particles and protein aggregates in biologic drug substances. The development of software products to support the biopharma industry pulls upon the company’s ~100 years of combined experience in the pharmaceutical industry, integrating solutions to meet the industry’s exacting standards. The technology behind ParticleSentryᴬᴵ forms a platform for current and future AI solutions within the biopharmaceutical space, with ParticleSentryAI as the DNA necessary to expand applications and imaging modalities.
SentrySciences LLC is a technology innovator and leading distributor and integrator of particle detection hardware, software and cleanroom management, quality assurance and cGMP compliance technologies for the pharmaceutical, aerospace, electronics, and semiconductor manufacturing industries.
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