Microbiology Testing Switzerland

Eurofins BioPharma Product Testing offers a comprehensive range of microbiology services with strict adherence to cGMP requirements in support of sterile and non-sterile product testing and facility monitoring for bio/pharmaceuticals, including raw materials and unprocessed bulk testing. We offer both clean room and isolator technologies for sterility testing, enabling application of the most appropriate technology for your products.

With seamless project management, our laboratory becomes an extension of your own operations, producing additional capacity to complement your internal microbiology laboratories.

Our harmonised testing methods support multiple compendia including USP, EP, JP and 21 CFR.

We have an assortment of specific instrumentation to suit your specific requests, including systems for Kinetic Turbidimetric / Chromogenic Endotoxin Testing, Genetic Analysers and MALDI-TOF for microbial IDs and Rapid Microbial Screening Systems.

Eurofins BioPharma Product Testing offers multiple technologies and approaches to Identification (ID) Testing to provide the appropriate level of identification to fit your needs. From identification of environmental isolates through expert analysis of finished product contaminants, we offer the most comprehensive ID services available for bacteria, moulds and yeasts. We use Genetic Analyser and MALDI-TOF for microbial IDs.

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:

• 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

Using MALDI-TOF Ms technology, as an alternative offering for routine identification of microorganisms. This is a rapid, high throughput efficient identification offering. 

Mycoplasma contamination of cell lines used to produce biopharmaceutical products can disrupt cellular growth and metabolism and lead to changes in gene expression, which results in decreased product quantity and quality. For these reasons, worldwide regulatory agencies require that biotechnological products produced in cell substrates be tested to ensure the absence of mycoplasma contamination.

The challenge with mycoplasma testing is that current procedures are time consuming, requiring a 28-day duration. However, this time requirement is not amenable for obtaining the rapid lot release testing results needed for biopharmaceutical products that have short half-lives or those that are in high market demand. The lengthy assay period is also not conducive to the rapid screening of raw materials intended for use in future production, nor to the rapid in-process screening of intermediates for the purpose of detecting and containing contamination events.