Biosimilar Assay Development
For those companies working to develop biosimilar therapeutics Cambridge Biomedical provides Assay Development, Optimization, and Validation services for use during pre-clinical and clinical trials of biosimilar biological products.
FDA requirements for biosimilar product development are located at:
Our specific areas of expertise include: de novo assay development, assay technology transfer, optimization and
validation of novel or commercially available kits. We work with biological matrices from humans or animals as well as both small and large therapeutic molecules.
Our development capabilities are supported by a CLIA certified, CAP accredited laboratory capable of
processing 10 or 10,000 samples.
Methods and Technologies
We seamlessly adapt to your needs, bringing experience with most assay development methods and technologies including:
PCR, ELISA, MSD, RIA, HPLC, cell based assays, IHC, Luminex®, and flow cytometry.