Product Development Depends on Robust and Reproducible Assays

 
 

We utilize a comprehensive range of technologies and methods applicable to both clinical trial and diagnostic testing to meet your specific assay requirements. 

Our research team is fast, flexible, and experienced. Once we get to know you and your product, we assemble a customized team of Ph.D.- and M.S.-level scientists, research associates, and medical technologists who specialize in your needs. You will have veteran scientists who become an extension of your environment and manage your projects from start to finish.

Cambridge Biomedical is CLIA-certified, CAP-accredited, and GLP-compliant. We offer consulting services to help you navigate quality and regulatory requirements from preclinical to Phase IV. Our skilled quality assurance team will ensure the integrity of your data at every step of the way.

 

Assay Development Capabilities

Our team has experience with de novo assay development, technology transfer, optimization, and validation of de novo or commercially available kits. We work with biological matrices from humans or animals, as well as both small and large molecules. 

Assays validated within our lab include a validation report customized to your exact requirements.

Validation Parameters:

  • Accuracy
  • Intra- and inter-assay precision
  • Interference
  • Linearity and dilution
  • Long-term stability at -80°C
  • Reportable ranges and clinical reference ranges
  • Short-term stability at RT and 4°C
  • Specificity and sensitivity
 
 

 When you need a fast, flexible, and experienced team for your assay development – be confident with Cambridge.