Microbiology and Molecular Biology Laboratory

In vitro diagnostic (IVD) and medical device development are dynamic and complex, where the pressure to develop new tests and protocols is growing quickly under changing user requirements. Because there are often no specific standardized processes available, creating innovative tests and methodologies necessitates designing testing strategies with tailored approaches. Developing an assay for product characterization and verification for products like COVID-19 polymerase chain reaction (PCR) tests, determining a product’s antimicrobial efficacy, or performing chemical characterization or contamination evaluation for a medical device requires extensive knowledge of a wide-range of microbiological, molecular, and chemical technologies and in-depth experience with the changing public health and regulatory landscape.

Exponent’s Microbiology and Molecular Biology Laboratory team specializes in quickly developing customized testing while adhering to industry quality standards. We have the in-house expertise to perform protocol development, quality control checks, and comprehensive microbiological testing, including antimicrobial testing, disinfection and cleaning assessments, and contamination sampling and analysis. Working with bacteria (e.g., Escherichia coli, Staphylococcus aureus, Burkholderia cepacia), bacteriophages (e.g., MS2), inactivated viruses (e.g., inactivated SARS-CoV-2), and other biosafety level 2 (BSL-2) pathogens, we can design model systems for comprehensive testing. Our customized approach also entails risk mitigation and failure analysis, through leachate evaluation and material analysis and characterization (e.g., for biocompatibility assessments), as well as assay development and verification.
Exponent’s Microbiology and Molecular Biology Laboratory offers services and instruments including:

Services:
  • qPCR
  • RT-PCR
  • Nucleic acid extraction
  • Enzyme assays
  • Protein assays
  • ELISAs
  • Lateral flow immunoassays

Instruments:
  • Incubator
  • Biosafety cabinet, class II type B2
  • Environmental chamber
  • Autoclave
  • Real-time PCR
  • Western blot transfer system
  • Plate reader
  • UV-Vis spectrophotometer

We also have ready access to ddPCR and sequencing equipment, as well as Exponent’s broader chemical analysis and characterization capabilities.

Professionals