Eurofins BioPharma Product Testing boldly goes beyond ID capabilities with IDmyk acquisition
Mark Kaiser, Senior Director, Microbiology, Stability Services and Lancaster Laboratories Midwest
Eurofins Biopharma Product Testing Group has expanded and enhanced its identification capabilities with the acquisition of IDmyk, a laboratory specialized in identification and molecular typing of microorganisms.
IDmyk, located in Lyon, France, offers the largest proprietary databases for sequence-based identification of bacteria, yeast and molds. The databases contain over 8,450 type strains of organisms relevant to the GMP regulated bio/pharmaceutical industry and are updated regularly with new organisms through a validated process. The use of double stranded long sequencing (1,350 base pairs) for bacteria as a standard approach improves the accuracy of the identification when compared with the partial sequencing (500 base pairs) commonly used in the bio/pharmaceutical industry. Multilocus Sequence Analysis (MLSA) is available and uses simultaneous comparative sequencing of multiple housekeeping genes of taxonomic interest and extended databases of reference sequences to increase resolution and further discriminate organisms at the species level.
IDmyk also offers extensive molecular typing services to generate fingerprints of isolates to determine if they correspond to different strains of the same species to support manufacturing contamination investigations. Services include MultiLocus Sequence Typing (MLST), Arbitrary Primed PCR (APPCR), Variable Number of Tandem Repeats (VNTR), Pulse Field Gel Electrophoresis (CHEF) and MicroSatellite Analysis (MSAT).
Integration of the IDmyk databases for sequence analysis into the Eurofins Biopharma Product Testing network of laboratories, including the microbiology laboratory in Lancaster, is in process and will provide a single global platform for clients using multiple Eurofins locations.
In addition, Eurofins Lancaster Laboratories (ELLI) has added the capability to identify bacteria using MALDI-TOF to its suite of identification services. MALDI-TOF provides a phenotypic identification using the unique protein patterns generated by organisms. ELLI uses the Bruker Biotyper platform and its validated database of over 4,600 organisms. ELLI is also expanding the reference library on an ongoing basis with the addition of species relevant to bio/pharmaceutical manufacturing environments and products. All entries to the library are confirmed through a formal validation process. The MALDI-TOF service option can provide clients with cost-effective identification in very short timeframes, including same-day service, and is ideal for routine identification of isolates from environmental and utility monitoring programs.
The addition of MALDI-TOF, the largest libraries of reference bacteria and fungi available worldwide for sequence analysis and specialized molecular typing through IDmyk, provides our clients with comprehensive identification services and the option to choose the appropriate level of identification to fit their needs, be it the identification of an environmental isolate or the analysis of an isolate from a critical investigation such as a media fill or sterility test failure.
For more information on identification capabilities, including sample submission instructions, pricing and turnaround time, please contact BioPharmaceutical Business Development at 717-656-2300.