Immunochemistry services provides quantitative immunoassays which are used to determine the levels of a biopharmaceutical in complex samples from clinical and non-clinical studies, such as plasma or serum
A concern that exists with biopharmaceuticals is the potential for the patient to develop an immune reaction to the drug itself following administration. Therefore, typical analysis of samples from clinical studies of biologics involve:
PK/PD analysis using a validated ELISA for the test biologic.
A parallel study using an ELISA for detection of antibodies raised in the patient against the drug (anti-drug antibodies, or ADA’s).
We have extensive experience in the design, validation and execution of bioanalytical studies to the strictest level of compliance with GLP practices, and can extend this wealth of experience to studies involving biologics. The range of detection platforms available for immunological assays include ELISA’s and Radio Immunoassay (RIA).