Validated microbial identification libraries provide pharmaceutical manufacturers with reliable species-level identification for a wide range of applications.
Charles River Laboratories
Pharmaceutical manufacturers engaged in biotechnology, pharmaceutical, medical device, home and personal care, and other related manufacturing industries need to be meticulous in creating and executing comprehensive microbial control programs to ensure products meet stringent quality standards. Identifying potential microbial contaminants in production areas quickly and accurately is critical to such activities. Older methods of microbial identification that are based on phenotypic characterization of microorganisms are no longer considered state of the art. The phenotypes of microorganisms that face strong environmental stressors can vary greatly, leading to unreliable and inefficient identification.
Moreover, traditional microbial identification techniques are resource heavy, necessitating lengthy incubation processes and supplemental testing that create workflow bottlenecks and subsequent lags in identifying and dealing with microbial contamination. Speed, convenience, and reliability are essential for pharmaceutical manufacturers seeking to stay on top of microbial identification as part of the regulatory demands in the biosciences.
Prepared microbial ID target plates are easy to load into the MALDI-TOF system for rapid and accurate microbial identification.
Charles River Laboratories
Proteotypic Microbial Identification
A modern approach to microbial identification involves capturing and differentiating unique protein signatures from bacteria and fungi for analysis with a powerful molecular technique known as Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS). Using this method, the unique peptide mass fingerprint (PMF) of the microorganism in question is compared to a library of PMFs for some of the most commonly encountered microorganisms. The main advantage of MALDI-TOF MS is the speed at which identification can be achieved – only fifteen minutes, compared to more traditional approaches that can take over eighteen hours.
The importance of MALDI-TOF MS databases in obtaining accurate and reliable identifications cannot be overstated. Databases that fall short of being large, diverse, and current can fail to represent the extensive range of microorganisms that exist in typical manufacturing environmental monitoring samples, leading to identifications that miss the mark. Public, clinically focused, and outdated databases from commercial identification systems are insufficient when it comes to identifying microorganisms from manufacturing environments. The downstream consequences of an inaccurate or "no identification" result can be risky and unsafe in regulatory environments that demand certainty in ruling out unwanted microorganisms in products and rapidly mitigating potential contaminations at early stages.
Going the Extra Mile for Strong Microbial Control
Charles River’s Axcess® MALDI-TOF System for microbial identification goes the extra mile with the Bruker MALDI Biotyper, an intuitive benchtop system. Integrated with this technology is the Accugenix® validated, curated reference library, which represents the largest industry-sourced global microbial database, with more than 17,500 strains across 5,900 species. The system enables high volume in-house capabilities, allowing pharmaceutical manufacturers to benefit from a compliant quality system that comes with assurances of reliability and control of the validated reference library as well as computerized systems, equipment, and related processes.
Meeting the standards of high-throughput labs that depend on rapid and reliable solutions, the Axcess® system can identify up to 96 samples in only fifteen minutes. As the backbone of the system, the Accugenix® database is updated on a frequent, regular basis to attune to the rapidly changing microbial landscape, which includes ongoing descriptions of new species and taxonomic changes. The robustness and scope of the database ensures that the Axcess® MALDI-TOF system has validated reference libraries of manufacturing-relevant bacteria and fungi, thereby optimizing the identification rate from environmental and product samples, improving confidence, and streamlining quality control workflows.
