With more than 100 years of microbiology experience, we are proud to offer our expertise in antimicrobial susceptibility testing (AST) and methodologies to support the pharmaceutical industry in new drug development. 

 

Our trusted brands, including the Thermo Scientific Sensititre AST System and Thermo Scientific Sensititre plates, with gold standard reference testing capabilities utilizing frozen broth microdilution plates, and Thermo Scientific Oxoid AST Discs with unparalleled quality, enable us to provide reliable products and testing services in all phases of new drug development and clinical trials.

Contact our experts

Request a no-obligation consultation on which services can support successful new drug development or clinical trials for your team.

Sensititre plate development

Development of new antimicrobials on 96-well microtiter plates utilizing the broth microdilution method, meeting CLSI, ISO, EUCAST, or other local requirements.* Options include:

Manual development

Development of novel antimicrobic for antimicrobial susceptibility testing in Sensititre broth microdilution dried plates for manual read methods.

Autoread development

Development of novel antimicrobic for antimicrobial susceptibility testing in Sensititre broth microdilution dried plates for automated methods.

Validation service

Equivalency studies comparing Sensititre dried plate to the broth microdilution reference method allowing use of dried plates in phase III trials.

Clinical trials

FDA/ISO/IVDR-compliant trials to support regulatory submission of AST devices.

Organism types available to develop on Thermo Scientific AST platforms are non-fastidious Gram negative and Gram positive bacteria, fastidious Gram negative and Gram positive bacteria, yeast, and mycobacteria.

Oxoid AST disc development

Development of new antimicrobials for disc diffusion methods meeting CLSI, ISO, EUCAST, or other local requirements.* Options include:

Performance evaluation-only development

Small scale development of handmade discs for research use only.

Commercial development

Large scale development of commercial Oxoid AST discs for IVD testing.

Clinical trials

FDA/ISO/IVDR-compliant trials to support regulatory submission of AST devices.

Organism types available to develop on Thermo Scientific AST platforms are non-fastidious Gram negative and Gram positive bacteria, fastidious Gram negative and Gram positive bacteria, yeast, and mycobacteria. 

Additional services and offerings

Reference testing

Comparison studies demonstrating performance of new AST devices and instruments against the broth microdilution reference method (frozen plate format).

Custom plates (frozen and dried plate format)

  • For use in supporting clinical drug trials for FDA, EMA/IVDR, and other* submissions. 
  • For use in supporting comparative validation studies.
  • For use in supporting development of custom plate/ancillaries for new compound development and surveillance testing

* Subject to regional regulatory requirements 

 

With a variety of services and methodology expertise, we aim to support and streamline new antimicrobial development for the pharmaceutical industry, and help ensure accurate AST options are introduced into the market to support clinicians and veterinarians in guiding optimal antimicrobial therapies, as well as research and surveillance applications in understanding antimicrobial resistance.

Resources

Antimicrobial susceptibility testing services for the pharmaceutical industry

Interested in learning more about our AST services? Contact us now for more information, or a quote: