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Microbiology

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We provide testing solutions for Raw Materials, active pharmaceutical ingredients, finished product biologics and medical devices. Teams are dedicated to method development, transfer and validation and we leverage best practices from the Eurofins network.

Sterile and Nonsterile products 

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 harmonized 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 Analyzers and MALDI-TOF for microbial IDs and Rapid Microbial Screening Systems.

  • Mycoplasma coming Q1 2021
  • Sterility
  • Endotoxin
  • Microbial Immersion Studies
  • CCIT under vacuum
  • Microbial Limits

 
  • Antimicrobial Preservative Effectiveness
  • Bioburden Testing
  • Disinfectant Efficacy Testing
  • Biological Indicator Analysis
  • Organism Identification
  • Growth Promotion

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, molds and yeasts. We use Genetic Analyzer 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 SequencingUses 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.
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Developing a Comprehensive Toolkit for Microbial ID

Developing a Comprehensive Toolkit for Microbial ID

Risk Management of Adventitious Agent Contamination in Biopharmaceutical Products

Learn how to avoid production delays through Eurofins Lancaster Labs' Webinar on Risk Assessment & Mitigation of Adventitious Agents.Learn about the application of various microbial identification methods, strain-typing techniques, microbial classifications, and the benefits of a comprehensive reference database

If you’re interested in working with Eurofins on a Biopharma project, fill out the form below and a member of our Team will be in contact to discuss your project.

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