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BIOMARKER AND IMMUNOASSAY SERVICES

QPS Pharmaceutical Services provides a wide range of biomarker/immunoassay services


Functional (cell-based assay, enzyme assay etc.) and quantitative assays of biomarkers in support of discovery/decision making process as well as development/clinical trial.
Determination of drug immunogenicity in support of IND/NDA submission.
Quantification of protein/peptide/DNA drugs for preclinical PK, TK as well as clinical studies.
GLP Compliant.
CLIA certified.
Bioplex system for simultaneous measurement of multiple biomarkers.
Automated Immulite immunoassay system.
Validated computer systems.

Biomarker Services

Biomarkers of drug effect can help improve PK/PD modeling and serve as an objective indicator of the progression of diseases at the molecular level. Biomarkers are necessary for efficient drug development when clinical outcomes are delayed in time or are very difficult or impossible to measure. Biomarkers can also play an important role in early phase, decision-making studies. QPS provides services in both functional assay and quantitative assay of biomarkers, including bioassays (enzymatic activity, ligand-receptor binding, etc.), cell-based assays (cytotoxicity, cell proliferation, cytokine secretion, etc.), and quantitative assay of molecular markers (e.g., cytokines, tumor markers, bone markers, reproductive hormones, thyroid hormones) using ELISA, multiplex assay (Bioplex) and automated immunoassay system (Immulite) in:

Method development
Validation
Enzymatic activity assay
Ligand-receptor binding assay
Cytotoxicity/cell proliferation assay
Assay for stimulation/inhibition of cytokine secretion
Validation of an existing kits/assay
Measurement of biomarkers in study samples of various matrices


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