Pharmaceutical Microbiology

The MALDI Biotyper® solution has been proven to support quality control teams to ensure the excellence and safety of their products thus significantly reducing downtime of production and delay in deliveries

Pharmaceutical microbiologists are responsible for ensuring that the supply of life-saving drugs and vaccines are free from contamination of microorganisms.

Straightforward to result

When a positive culture is detected in a sample along the process-chain e.g. in raw-material or an end-product, or in the production environment, identification of the cultured microorganism is required. The MALDI Biotyper is a Rapid Microbiological Method for identification based on the unique proteomic fingerprint of an organism. The ready-to-use reference library comprises thousands of individual strains and covers explicitly industrial quality control.

Thus, even demanding microorganisms like anaerobic and non-fermenting bacteria as well as multicellular fungi can be identified with one approach. No expertise in mass spectrometry is required and the identification can be obtained in-house within minutes. Implementing MALDI Biotyper in the QC workflow can translate to high cost savings in terms of saving lost product shipments and production line uptime.

Broad species coverage

The MBT Compass reference library currently contains 7,311 reference spectra of 2,509 species from 433 bacteria and fungi genera. The library is continuously maintained and updated according to strict quality controlled procedures.

In addition to the reference library, specific libraries for filamentous fungi and mycobacteria are also available.

Creating own libraries

Laboratories that need to create their own libraries can make use of software tools to easily compile customized microorganism entries. Sophisticated bioinformatics for spectra comparison and statistical data interpretation enables users to optimize the microorganism classification process by creating, modifying and organizing reference spectrum data. Customer-generated libraries can be easily exchanged e.g. between laboratories at other plants of the same company.

Process control

Already in use in a number of pharmaceutical microbiology labs, the MALDI Biotyper provides a very rapid and specific microbial identification comparable to molecular sequencing resolution but with significantly less effort, time and cost. The implementation and validation of the MALDI Biotyper is supported by IQ and OQ-PV documentation and 21 CFR Part 11 supporting software. For daily routine documentation requirements, the MALDI Biotyper solution offers complete workflow traceability.