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Immunological Test Service

Immunological test method is valuable and popular for pharmacokinetics analysis due to its high sensitivity and specificity for the analyte in complex system. This method is used to measure the quality attribute of the biological drug basically depending on the interaction between the antibody and antigen. Generally, immunological test have higher precision and shorter time than traditional biological assay (cell based and animals).

Creative Proteomics offers several types of immunological test services:

Immunological test services used in biopharmaceutical pharmacokinetics

Method	Advantages	Disadvantages
ELISA	High sensitivity Wide dynamic range High throughput Low cost	Multistage process highly dependent on proper execution of each stage Wash steps add tine and often biohazardous waste Reagent labeling required
RIA	Binding occurs in native conformation Low-concentration samples can be analyzed High sensitivity antibody used at limiting dilution Can be plate-based for higher throughput	Requires radioactive labeling for detection Shorter half-life of some radioisotopes requires periodic preparation of the tracer Hazardous waste
Flow cytometry	High throughput Highly automated	Use limited to cells, particles and samples bound to beads Sensitive to aggregates and sample matrix
SPR	Direct detection of binding Measure affinity precisely, including on and off rates	Immobilization can alter binding Regeneration can alter binding Low throughput, output

* reference see The United States Pharmacopeia (USP 35-NF 30)

*For Research Use Only. Not for use in the treatment or diagnosis of disease.

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