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Assay Development
Speed, Flexibility and customization
Rapid assay development qualification procedures shorten your time from engagement to results. Cambridge Biomedical can develop an assay in different stages:
- De novo assay development.
- Full assay research and development.
- Commercially available kit validated to meet custom specifications.
- Biological matrices; animal or human.
- Technology transfer an assay from your laboratory to ours with optimization to meet commercial standards.
- Our procedures and protocols comply with FDA guidelines and are flexible to be custom designed to client specific requirements.
- Our capabilities extend from small molecules to large proteins.
- Our team has expertise and experience in a wide range of methods and technologies to support your assay requirements, including: PCR, ELISA, HPLC, Cell Based, and flow cytometry.
Experience
- Cambridge Biomedical has been developing and validating assays for 15 years.
- Our team has developed and validated over 150 assays used for commercial diagnostics, clinical trials and research and development.
- Experts in microbiology, molecular biology, immunoassay development and biomedical and clinical chemistry.
- Trusted partner with pharmaceutical, biotech, medical device, universities, hospitals and diagnostic companies.
- Our quality assurance unit has experience with technology transfer, key specifications and metrics, SOPs and protocols, submission grade reports and overall project management.
- Our team is comprised of experienced and dedicated Ph.D.'s, MD's, and medtech's.
Cambridge Biomedical is CLIA certified, CAP accredited, and provides services that support best laboratory practices and GLP compliance. We help our clients navigate through quality and regulatory requirements from preclinical to IV studies.
