Cambridge Biomedical: your occupancy expert.
Cambridge Biomedical has extensive experience in developing receptor occupancy assays in soluble proteins for pharmacodynamic studies. One example is Bruton's tyrosine kinase (Btk), an enzyme that plays an important role in B-cell receptor signaling.
Btk regulates the proliferation and survival of cancer cells in various B-cell lymphoid malignancies. We have successfully developed, optimized, and validated various ELISA based assays to determine the Btk occupancy in PBMC lysates. We are well versed in this field to produce high-quality services that meet Good Laboratory Practices (GLP) regulatory standards as stated in 21 CFR Part 58.
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From point of blood sample collection to occupancy testing, we are capable of acting as a central laboratory for Phase I/II studies from sample collection kit preparation to whole blood PBMC isolation and processing and lysate sample preparation for testing.
We pride ourselves in our ability to overcome rigorous challenges.
Our assay validation process includes Precision, Accuracy, Short and Long Term Stability of Analyte (endogenous and drug-bound), Freeze-Thaw Stability, Dilution and more. Our validation process can be custom built to our client specifications and in accordance with FDA guidance on Bioanalytical Method Validation.