bioMérieux SA
F-69280 Marcy l'Etoile
France
phone: +33 04 78 87 20 00
email: biopharma@biomerieux.com
website: www.biomerieux-industry.com/ms
bioMérieux, a world leader in the field of in vitro diagnostics, announced today the launch of the VITEK®MS automated identification system for the Pharmaceutical Industry. Using the MALDI-TOF Mass Spectrometry technology and a database developed by bioMérieux for bacterial and fungal identification, VITEK MS provides rapid, robust and accurate identifications. The 21CFR part 11 compliance of the VITEK MS offers the traceability needed by pharmaceutical laboratories.
Accurately identifying potential microbiological contamination of sterile processes and products is essential for pharmaceutical manufacturers. The VITEK MS can reduce this microbial identification time to a few minutes using molecular analysis of proteins from isolated colonies. Other benefits include a very small sample size, minimal analyst hands-on time, and flexibility for use in different kinds of pharmaceutical industry laboratories.
“bioMérieux is pioneering the future of microbial identification in the pharmaceutical industry with VITEK MS,” says Jean-Marc Durano, Corporate Vice President, Industrial Microbiology Unit. “We worked closely with pharmaceutical customers to validate the new solution and it offers an excellent complement to our Pharma Solutions portfolio, which includes: API®, PREVI® Color Gram and VITEK® 2 Compact.”
The VITEK MS system and performance results have already been presented at different conferences such as PDA Microbiology Europe, where it was presented by Sanofi Pasteur in February 2012. The system is now available worldwide for the pharmaceutical industry.
About VITEK MS for the Pharmaceutical Industry
VITEK MS provides ultra rapid results:
Directly deposit the microorganism on the target slide, add the ready-to-use matrix solution and insert slide into the VITEK MS system. Identification results are displayed within minutes.
VITEK MS offers security and traceability:
Not only is VITEK MS 21 CFR Part 11 Compliant, but the VITEK MS includes the VITEK® MS Prep Station, which securely links specimen information with each spot on the target slide. Unique barcodes on the plated media and the VITEK MS target slides offer complete workflow traceability.
VITEK MS provides accurate identification:
The VITEK MS database, which contains a large number of specific microorganisms for the pharmaceutical industry, was developed from multiple regions, countries, sources and environments. In addition, our proprietary algorithm vastly increases the accuracy of identification.
VITEK MS is flexible:
VITEK MS can be integrated into quality control laboratories with either centralized or decentralized workflows by utilizing its unique VITEK MS Prep Station. This flexibility allows multiple users to work in parallel by preparing their own target slides with the capability to identify up to 192 isolates per run.
About Mass Spectrometry
Mass spectrometry (MS) is an analytical technique for determining the elemental composition of a sample. The MS principle consists of ionizing chemical compounds to generate charged molecules and to measure their mass-to-charge ratio. Such molecular “signatures” can be used for rapid bacterial identification (ID) from isolated colonies. The use of mass spectrometry for bacterial ID is especially suitable and cost-efficient for laboratories with high volumes of samples.
About MALDI-TOF
MALDI-TOF technology (Matrix Assisted Laser Desorption Ionization Time-of-Flight) used by VITEK® MS examines the patterns of proteins detected directly from intact bacteria. The sample to be analyzed is mixed with another compound, called a matrix. The mixture is applied to a metal plate and irradiated with a laser. The matrix absorbs the laser light and vaporizes, along with the sample, in the process gaining an electrical charge (ionization). Electric fields then guide the ions into the time of flight mass spectrometer, which separates them according to their mass to charge (m/z) ratio, and ultimately the quantity of each ion is measured. Detection is achieved at the end of the flight tube.
For more information, visit www.biomerieux-industry.com/ms.