Since its establishment in 1997, Cambridge Biomedical has supported sponsors and CRO’s developing customized assays for small and large molecules, biomarkers, diagnostics, and medical devices. Our team has expertise and extensive experience in technology transfer, assay development, optimization, and validation. We are positioned to work with you at preclinical, clinical, and post market stages of drug or device development.
Cambridge Biomedical employs senior scientists at the PhD, MD, and MD/PhD level. Our accomplished staff are experts in complex and custom assay development and validation. Given our technical experience and scientific expertise, Cambridge Biomedical is able to perform across a broad range of therapeutic areas.
Since inception, Cambridge Biomedical has developed, qualified, and validated over 150 assays, with an average of 15-20 additional assays per year. We provide sample analysis on over 100,000 samples annually.
Certifications: GLP Compliance, CLIA certified, CAP Accredited
"Lab Developed Tests" by Dr. John Reddington Ph.D. D.V.M.
"Luminex Assay Validation" by Dr. Archana Kapoor Ph.D.
"Collaborative Assay Development" by Dr. James Lederer Ph.D.
"A High-Throughput Multiplexed Assay For Super Family-Wide Profiling of Enzyme Activity" by Dr. Dan Bachovchin Ph.D.
Cambridge Biomedical has developed numerous PCR, qPCR, and RT-PCR assays utilizing our fully equipped and dedicated PCR suite with the latest generation of PCR equipment including Applied Biosystems ViiA 7 (96 wells, 384 wells, fast cycle), Taqman Low Density Arrays (TLDA), and the Applied Biosystems Prism 7000.
Our scientific team brings a wide range of experience in developing, validating and optimizing PCR assays.
Electrochemiluminescence or electrogenerated chemiluminescence (ECL) is a type of luminescence produced during electrochemical reactions in solution. Cambridge Biomedical uses the MesoScale Discovery (MSD) platform allowing the detection of biomarkers in single and multiplex formats in microplate wells.
Typical applications of electrochemiluminescence:
• Cytokines and chemokines
• Cell signaling pathways
• Angiogenesis and hypoxia markers
• Growth and vascular factors
• Metabolic markers
• Cell based assays
Advantages of ECL over conventional ELISA:
• High sensitivity and low background because the stimulation mechanism (electrical)
is decoupled from the detection signal (light)
• Emission read at 620 nm, eliminates issues revolving around color quenching
• Improved precision from non-separation-based ("no-wash") immunoassays due to the
proximity-based nature of signal generation, where only labels near surfaces of
electrodes are stimulated
• A large assay dynamic range of five logs
• Carbon electrode plate surface has a 10X greater binding capacity than
conventional ELISA microplates
• Multiple analytes can be run in a single well, reducing required sample volume
Cell based assays offer a more accurate representation of a real life model since live cells are used. They also offer the possibility of a dynamic experiment through monitoring the numbers or behavior of live cells. We can recommend strategies and provide contract services for:
• Cell-based assays
• Measuring neutralizing antibodies
• Tissue culture
• Cell culture optimization
• Bioassays including stem cells and protein expression
• systems for large-scale tissue culture
Cambridge Biomedical offers a number of different cell based assay experiments, including assays that measure:
• Cell proliferation
• Production of a measurable product
Flow Cytometry is a powerful technique for rapidly analyzing large numbers of cells individually using light-scattering, fluorescence, and absorbance measurements. The use of multiple markers in polychromatic Flow Cytometry has a host of applications in basic research, drug discovery, and the clinical laboratory.
Cambridge Biomedical is positioned to assist you with specialized Flow Cytomtery or Fluorescence-Activated Cell Sorting (FACS) assay development, validation, optimization, and sample analysis needs. Our facility operates multiple FACS Canto II systems.
The advantages and applications of Flow Cytometry include:
• Capability to simultaneously analyze multiple parameters for a given cell population
• High throughput cell and particle based screening and analyses
• In depth analysis of complex cellular processes such as oncogenesis, cell cycle regulation,
autophagy, apoptosis, necrosis, senescence, cell proliferation, and functional studies
within phenotypically defined populations, such as calcium flux and phosphorylated proteins
• Intracellular and cytoplasmic antigen analysis, and organelle analysis
• DNA and RNA analysis
• Translocation assays
• Screening for ploidy, immunophenotyping, oncological, and disease-associated
biomarker analysis and monitoring
• Whole cell and receptor binding assays, cell counting, functional G-protein-coupled
• In vitro toxicology, antibody screening, and rare event analysis, such as in dendritic cells,
and stem/progenitor cells
Luminex®/Quantigene® is a fluorescence covalent microbead immunosorbent assay. Up to 500 analytes can be multiplexed in a single well, the most commonly used Luminex® x-MAP technology is a flexible, open architecture design that can be configured to perform a wide range of bio-assays.
The Cambridge Biomedical laboratory operates two Luminex® FLEXMAP 3D systems with xPonent software.
ELISA assays in multiple formats, including—colorimetric, fluorescence, electrochemiluminescence.
In support of your discovery work or clinical trials, we bring extensive experience studying metabolic processes and analysis of the metabolites. We can recommend strategies and provide contract services as follows:
• HPLC with UV or fluorescence detectors
• Kinetic and/or end-point enzymatic assays
• Enzyme inhibition studies
Methods and Technologies:
We seamlessly adapt to your needs, bringing experience with technologies including colorometric and fluorescent testing and HPLC.
Immunogenicity testing evaluates drug safety, and as such, these tests are essential components in the development of biotherapeutic drugs.
Cambridge Biomedical has developed and validated many different immunogenicity assays for the purposes of both clinical diagnostics and clinical trials, and against a variety of invading microorganisms in patient samples and administered drugs.
We can recommend strategies and provide contract services for assessing immunogenicity utilizing the following technologies:
• ELISA (Enzyme Linked Immunosorbant Assay)
• RIA (Radio Immunoassay)
• MSD (Mesoscale Discovery, Electrochemiluminescence)
• Binding assays
• Cell based neutralizing assays
• Flow cytometry
Cambridge Biomedical is CLIA certified, CAP accredited, and provides services that support best laboratory practices and GLP compliance. We help you navigate through quality and regulatory requirements from preclinical to phase IV studies.
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.
We can detect and quantify (or semi-quantify) cytokines, chemokines, and their receptors, both cell bound and free. Analysis of any combination of cytokines and chemokines can be done in a variety of body fluids, tissue/cell lysate, and culture supernatant samples. We can recommend strategies and provide contract services for:
• Multiplex of up to 500 targets utilizing Luminex® technology
• Intracellular cytokine analysis using flow cytometry--up to five at one time
• MesoScale Discovery (MSD) and ELISA
• qPCR using 96 and 384 well plates, or open array card
Methods and Technologies:
We seamlessly adapt to your needs, bringing experience with technologies including: qPCR, ELISA, MSD, RIA, Luminex®, and flow cytometry.
Our technicians average eight years' experience in their platform specializations, assuring your organization of the highest level laboratory work.
Understanding the PK/PD behavior of a drug helps design the dose, route, and schedule of administration to maximize effectiveness while reducing adverse effects.
Bioanalytical testing methods are utilized to determine concentration time profiles of the drug and metabolites in biological fluids, providing information necessary for PK/PD analysis. High performance liquid chromatography (HPLC) and Immunoassay, MSD and Luminex® technologies are selective and sensitive bioanalytical methods utilized in our laboratory to implement your PK/PD studies.
Our bioanalytical capabilities for PK/PD include:
• Sample preparation (PP, LLE, SPE)
• HPLC method optimization
• UV-Vis or fluorescence detection
• Customized ELISA bioassays
Our development capabilities are supported by a CLIA certified, CAP accredited laboratory capable of processing 10 or 10,000 samples.
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