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Custom Biopharmaceutical Services:
Preclinical Contract Research, Biologics Testing, Bioassay Development, Customized LC-MS/MS and HPLC-UV method development and validation. Sample analysis for clinical and non-clinical studies. Pharmacokinetic/Toxicokinetic studies (pre-clinical and clinical). Lot release evaluation. Dose formulation analysis. Residual contamination testing. Plasma protein binding. Metabolic stability and profiling. ELISA format drug quantification. Custom assay development, optimization and validation. Ligand binding assays. o Electrochemiluminescence (MesoScaleDiscovery). o Fluorescence o Luminescence Pharmacokinetic/Toxicokinetic studies (pre-clinical and clinical). Immunogenicity/anti-drug antibody assays. Cell-based bioassays (neutralizing antibodies, potency). Flow cytometry. Residual contaminant/host-cell protein assays.