Assay Development & Optimization
Our assay development teams are fast responders, flexible, and experienced.
We assemble the appropriate team of PhD, MD, and laboratory technicians required to successfully meet your work requirements. Our team becomes an extension of your environment; filling needs and helping meet and accelerate your development timeline.
Cambridge Biomedical has developed more than 150 assays since 1997--for every phase of clinical trial, for companion diagnostics and for R&D applications (see “Case Studies” below).
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 clinical diagnostic testing laboratory capable of processing 10 or 10,000 samples.
Methods and Technologies
Our flexibility and expertise, offers our clients most assay development methods and technologies including:
PCR, ELISA, MSD, RIA, HPLC, cell based assays, IHC, Luminex® and flow cytometry.
Quality Assurance Unit (QAU)
Our QAU remains independent from operations, reporting directly to the president/CEO. Their responsibilities under our GLP-compliant quality system include:
• Document control via CARA Documentum
• Training management via UL EduNeering ComplianceWire
• Archive management by the GLP archivist
• Internal quality system and vendor qualification audits
• Critical phase and data/report audits (as applicable)
• Client and regulatory body inspections
• Recommendations to and consultation with operations management for
• continuous improvement and process improvement initiatives
• Regulatory and quality risk minimization