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.

The SCANRDI® is an ultra-rapid alternative technology for detecting microbial contaminants in drug products. Designed to meet compendial testing standards, studies on Limit of Detection (LoD) and Equivalency have been performed with a focus on species listed by the Pharmacopeias microorganisms. 

Testing for mycoplasma contamination is a required release test for Cell & Gene Therapy (CGT) products as specified in the major pharmacopeias(1-3).

Environmental Monitoring (EM) is crucial to assure patient safety. The visual end point reading of petri dishes has been used for decades without a true performance assessment. Automatization technologies are more present and improve EM practices

Automated culture systems are widely used for rapid-real-time microbial contamination detection for pharmaceutical products including small molecule, bioproduction, and cell and gene therapy

This poster presents results from independent studies performed by 4 bioproduction companies using the BIOFIRE® Mycoplasma system that can detect >130 species of mycoplasma. The BIOFIRE® filmarray system condenses all the steps of a conventional PCR test into an enclosed pouch and provides sample to answer in less than one hour with as little as 2 minutes of hands-on time.

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).