CPSA 2011

Science and Technology Coming Together to Make a Difference

October 3 - 6, 2011
Bucks County Sheraton Hotel
Langhorne, PA

Program Abstract

Wednesday, Lunch & Learn Session

New Horizons for MALDI-TOF MS: Are there bugs in my drugs?"

Gary Kruppa
Vice President, Business Development
Bruker Daltonics

Pharmaceutical microbiologists work to insure the sterility of the manufacturing environment, intermediates and final pharmaceutical products. Using swabs, air filters, water filters, and product samples, followed by culture, these microbiologists monitor facilities, raw materials, intermediates and products for the presence of viable organisms by culture. If growth is detected, identification of the microorganism is often mandatory to determine the likely source of the contamination and help guide remedial work.

The use of automated biochemical methods, sequencing and other genetic techniques such as the Riboprinter are common in the pharmaceutical microbiology lab. These techniques can take from 6-48 hours after growth is detected to produce an identification, and cost anywhere from $4 to $60 per ID. For critical cases, production and/or product release may be held up pending the identification result, at great cost to the company. The MALDI Biotyper employs MALDI-TOF technology to produce a protein fingerprint which can be used with a database of such fingerprints to identify microbial species within minutes after positive culture, thus potentially generating tremendous cost savings. Also, with a consumables cost per test of about $0.20 per sample, labs that process a large number of samples can generate significant cost savings over other ID methods. The MALDI Biotyper method covers a wide range of Gram positive and Gram negative bacteria, yeast and fungi. The use of MALDI-TOF technology for microbial identification will be introduced, and compared to other methods currently in common use. Applications of the MALDI Biotyper to clinical, industrial, and pharmaceutical microbiology will be presented.

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