Accugenix provides superior services for microbial identification for routine tracking and trending
By taking advantage of our AccuGENX-ID™, AccuPRO-ID®, AccuBLAST® and strain typing services, we can provide you with accurate, consistent and reliable microbial identifications. The proprietary services offered by Accugenix are a perfect solution for routine monitoring and alerts.
Utilizing the most accurate microbial identification methods while conducting gridding studies of your manufacturing plant and performing routine screenings provides you the ability to recognize and identify reoccurring excursions of the same organism. Likewise, an increase in the number of microorganisms recovered in certain areas of the facility may indicate breaches in the HVAC system or other sources of microbial contamination. A recognized shift in the types of organisms recovered from the area may be helpful in locating the source of contamination.
If your manufacturing facility still relies on dated phenotypic methods to determine the identity of microorganisms, recognize that these methods are not always reliable. As an example, we have found that even a species-level identification with a 96% confidence value can be 100% incorrect. Inherently dependent on the health and growth conditions of the organism, as well as the relevance of the database used to determine the organism’s identity, phenotypic methods can often yield erroneous and inconsistent identifications. Reliable microbial ID systems are required to give consistent and accurate results for tracking and trending. Identification methods which provide inconsistent identifications or no identification for the same isolate are not useful for tracking isolates to their source or for generating trending reports. Additionally, if a health claim is made for a probiotic, the Latin name (i.e., genus and species) of the probiotic microorganism that is the subject of the claim should be declared. Consistent identification of your source organisms is a necessity.
According to the FDA’s Guidance for Industry, “The goal of microbiological monitoring is to reproducibly detect microorganisms for purposes of monitoring the state of environmental control. Consistent methods will yield a database that allows for sound data comparisons and interpretations.” (Guidance for Industry Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice, 2004).
Reduce your risk
The adoption of consistent, reproducible methods, such as genotypic or proteotypic, negates the need to characterize microorganisms by phenotypic methods. When you know that the methods you are using to obtain your identifications are dependable, you can be certain that tracking the organisms in your production environment or the organisms that are your product, by the name will be accurate and consistent.
As we know, in the world of music and microbiology – names change. Genotypic methods for identification, strain typing and characterization are based on the DNA of an organism, which may exhibit but one nucleotide mutation every 3 million years. The DNA sequence alone is a superior descriptor than a name and provides a better tool for tracking and trending than any phenotypic method. By employing AccuGENX-ID™, or AccuBLAST®, for your routine monitoring, you will obtain the sequence identifiers for your microbial ecology, and if a name changes due to developments in taxonomy that reclassify an organism, you can still track the organism since the sequence will not have changed.
Accugenix can provide a definitive determination of strain type to locate the source of contaminations and excursions
When there is a major excursion, a sterility failure with a product on hold or production that ceases, thorough characterization of the microbial population in the manufacturing environment through strain typing is the preferred method for sourcing the contaminant. Once a thorough genetic description is generated, it can contribute to determining a root cause. Thus allowing you to remediate the situation and determine a corrective action plan.
Investigative programs that only utilize the genus and species name of an organism may not provide enough information to make definitive conclusions in an investigation. The species name alone may not provide the appropriate information to develop a response to a contamination event if there is the potential for multiple strains as sources for that contamination. Many times it is necessary to differentiate microbial flora to the sub-species or strain level to definitively determine the source of contamination. Additionally, strain typing is critical for the probiotics industry to assure that the exact strain of the probiotic microorganism in production is established.
Services offered by Accugenix for strain typing
AccuGENX-ID™ and AccuBLAST® provide accurate, reproducible and reliable species-level identifications. Resolution below the species level to the sub-species or strain level usually requires single or multi-locus sequence typing (SLST, MLST) or ribotyping methods. In some cases, ribotyping is ineffective as some species have very little diversity within the ribosomal RNA operon analyzed by the RiboPrinter®. With the addition of sequence-based methods for strain typing and characterization (SLST and MLST) to the Accugenix services menu, we can provide a higher level of discrimination and repeatability than automated ribotyping.
