EVALUATION OF VITEK® MS PRIME FOR IDENTIFYING PHARMACEUTICAL STRAINS IN INDUSTRIAL QUALITY CONTROL

Microbial identification is a cornerstone of pharmaceutical industrial quality control, ensuring product safety and compliance with regulatory standards.

According to EU GMP Annex 1, Chapter 9.31, and USP <1113> guidance, manufacturers are required to identify microorganisms to the species level when investigating contamination or monitoring environmental trends. This level of precision is critical, as genus-level identification may overlook strain-specific risks such as pathogenicity, resistance profiles, or spoilage potential.

Modern technologies like MALDI-TOF mass spectrometry offer rapid, accurate, and cost-effective species-level identification, making them ideal for routine use in industrial QC. The VITEK® MS PRIME system exemplifies this advancement, providing robust microbial ID capabilities that align with regulatory expectations and support contamination control strategies.

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VITEK^®MS PRIME MALDI-TOF Mass Spectrometry System

The VITEK® MS PRIME is the next level of automated MALDI-TOF Mass Spectrometry system, that allows an accurate identification to the species-level.

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Microbial Identification

Make confident decisions about the quality of your product with trusted and accurate identification solutions. Whether your lab is seeking for manual, or rapid and automated testing, we have your covered!

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Differentiation within the Bacillus Cereus and Bacillus Subtilisgroups with Maldi-Tof

Bacillus cereus group is composed of B. anthracis, B. cereus, B. cytotoxicus, B. mycoides, B. pseudomycoides, B. thuringiensis and B. weihenstephanensis.

Bacillus subtilis group is composed of B. amyloliquefaciens, B. subtilis, B. vallismortis, B. velezensis.

They are well known pathogens among the Bacillus genus and can be a source of human infection as well as contaminants in agriculture and food industry. These species are very similar and their differentiation is cumbersome but essential notably in term of epidemiology.

Today, no mass spectrometry system is able to differentiate them in routine. The biochemical or molecular techniques are quite fastidious, long and expensive and not always conclusive.

The objective of this study was to develop a simple and user-friendly method to separate these species by MALDI-TOF.

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ACM Pharma uses VITEK® MS PRIME to ensure their microbial identification activities and sustain their business.

ACM Pharma is a leading subcontracting laboratory dedicated to serving the Bio/Pharmaceutical, Medical Devices, Cosmetics, and Disinfectants industries. Their Operational Director explains why they chose and use VITEK® MS PRIME to ensure their microbial identification activities and sustain their business.

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