Microorganism identification and typing support
Microbial detection
Speed, accuracy, and compliance
In GMP-regulated environments, microbial contamination can not only impact product quality, it can bring operations to a standstill. Cleanrooms—supposed to be controlled sanctuaries of pharmaceutical manufacturing—can quickly become high-risk zones when microbial contaminants go unclassified. Annex 1 and other regulations demands you act fast. But without the in-house equipment, databases, or expertise to respond with precision, the consequences can be significant: costly delays, batch rejections, or worse—loss of product integrity. The challenge lies in the countless number of microorganisms, the number of traits, the representativity of included species, and the comprehensiveness of the database needed in order to generate the most accurate identification.
The Eurofins BioPharma Product Testing (BPT) network of laboratories offers cost-effective expertise, speed, and reliability to overcome these challenges. Delivering over 25+ years of microbiology-driven solutions to the pharmaceutical industry, our microbial identification and typing services are engineered to safeguard both product and process, while keeping you in line with the latest regulatory expectations.
Our laboratories offer the most comprehensive identification services available, using multiple state-of-the-art technologies. From environmental isolates to finished product contaminants, we identify bacteria, moulds, and yeasts with pinpoint precision. After identification, we conduct risk assessments to evaluate the threat to both the product and process, which allows you to determine possible sources of contamination.
Services Available
Genotypic identification
Unilocus comparative sequencing (ULSA)
Bacteria: 16S rRNA gene long sequencing
Uses PCR to amplify more than 1,350 base pairs, double strand sequencing and comparison to our validated, proprietary database, Eurofins Microbial Sequencing Index (EMSI), including more than 9,260 valid type strains.
- Genus and species level identification
- More accurate than partial sequencing
- Rapid, reliable and efficient
Fungi: 25S rRNA gene or ITS1/ITS2 partial sequencing
Uses 25S rRNA gene.
- Genus and species level identification
- Rapid, reliable and efficient
Multilocus sequencing (MLSA)
Solves drawbacks from 16S rRNA (bacteria) or 25S rRNA genes, ITS1 and/or ITS2 (fungi), sequencing by increasing resolution to further discriminate at the species level.
- Simultaneous comparative sequencing of multiple genes (housekeeping genes) of taxonomical interest and extended databases of reference sequences: bacteria and moulds.
- Application to strain typing (MLST).
Proteotypic identification
MALDI-TOF mass spectrometry organism identification
Bacteria and yeast identification
Uses MALDI-TOF mass spectrometry to create a unique proteomic fingerprint of an organism. This fingerprint is matches characteristic patterns within the instrument library. The instrument library consists of over 11,000 entries that span more than 4,000 species of bacteria and yeasts.
- Gene and species level identifications
- Rapid identification testing
- More cost-effective method
Molecular typing
To characterise strains within the same species.
To compare strains of the same species with each other.
- Multilocus sequencing (MLST)
- Single nucleotide polymorphisms (SNPs)
- Tandem repeat region polymorphism (VNTR)
- Pulsed field electrophoresis (CHEF)
- MicroSatellite sequence analysis (MSAT)