Rapid Microbiology
Rapid detection of microbial contamination in pharmaceutical and food and beverage environments demands highly sensitive and reliable technologies. Today using rapid detection methods for routine testing is still a challenge for many industries. Culturing and plating methods are the oldest bacterial detection techniques yet continue as the standard detection methods. These methods require several days for results because they rely on the time it takes for microorganisms to grow and to multiply in order to be visible colonies. Moreover, culture media preparation, inoculation of plates and colony counting make these methods labor intensive and time consuming. Over the two past decades, many technologies such as Enzyme-linked immunosorbent assays (ELISA), impedence, flow cytometry and real-time polymerase chain reaction (PCR) have developed in the field of rapid detection.An alternative approach to monitor bacterial contamination is to use Adenosine Triphosphate (ATP) bioluminescence technology. ATP is found only in living cells and is a direct indicator of cell viability. ATP is also a universal energy molecule stored in all microorganisms. Methods based on ATP bioluminescence have been developed and widely used to monitor surface contamination and to detect contaminants in raw materials, intermediates and final products.
Click here if you are from a non-pharmaceutical company and want to learn more about Rapid detection methods based on ATP Bioluminescence. If you are from a pharmaceutical company, click here for more information on Rapid Detection.
A different approach facilitates the usage of nucleic acid technologies (NAT). These non-culture based methods are highly sensitive and specific. One bacterial cell can contain up to 10,000 copies of ribosomal RNA (rRNA), as opposed to the single or several copies of DNA. The abundance of rRNA translates into assay robustness and a greater potential for single cell detection. As an example the Real-Time Transcription-Mediated Amplification (TMA) technology is a nucleic acid based method that amplifies rRNA to detect targeted microbial contamination within 4 hours.
Millipore and Gen-Probe have formed an alliance to develop, manufacture and commercialize on an exclusive basis nucleic acid testing (NAT) products for rapid microbiological and virus monitoring in the biotech and pharmaceutical industries. Millipore’s sample preparation technology can isolate a single microorganism from large volumes of fluid. Gen-Probe’s TMA technology can amplify and detect minuscule quantities of microorganism-specific RNA in hours or less. The MilliPROBE system was recently launched as the first result of the cooperation from these two industrial leaders in microbiology.
Detecting mycoplasma contaminations in cell culture samples is of major concern. Current methods for positive detection of species belonging to this genus include plating onto agar and liquid co-cultures with VERO cells followed by DNA staining. Although these technologies yield sensitive and reliable results the time to result is typically 2 – 4 weeks. The patented Hybridization Protection Assay assay format from Gen-Probe, in which a labeled DNA probe is hybridized to the conserved region of the released rRNA of the target organisms, reduces the time to result dramatically. During detection, the bound probes will produce chemiluminescence signals presented as Relative Light Units (RLUs) where a positive signal is defined as a value above a certain threshold value.
If you want to learn more about Rapid screening products based on NAT technologies, click here.
Pharmaceutical Quality Control
Beverage Analysis
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