Bioanalysis

Bioanalysis

Scinovo support both small and large molecule drugs for nonclinical and clinical studies using LC-MS/MS, Simoa, MSD and FACS platforms. We could provide excellent bioanalytical services in compliance with standards of GLP/GCP and guidances of ICH/EMA/NMPA and FDA. Our bioanalytical team has extensive professional experience, especially in bioanalysis of endogenous compound, chiral drug, unstable drug and ADC drug.

We shall provide services of method development, transfer, validation and sample analysis to support biosimilar clinical comparability/generic bioequivalence, new drug PK/TK, immunogenicity, and biomarker/PD studies etc.. Scinovo would consistently provide high-quality and high-efficient bioanalytical services from study design to submission.

Small Molecule Bioanalysis

Small Molecule Bioanalysis

Pharmacokinetics (PK) Bioanalytical Services
Toxicokinetics (TK) Bioanalytical Services

Large Molecule Bioanalysis

Large Molecule Bioanalysis

Pharmacokinetics (PK) Bioanalytical Services
Toxicokinetics (TK) Bioanalytical Services

Immunogenicity Bioanalytical Services:
· Anti-drug Antibody (ADA) assays: screening assay, confirmatory assay and titer assessment.
· Non-cell/cell based neutralizing antibody (Nab) assays

Cell Therapy Products

Cell Therapy Products

· CAR-T or Stem cell products etc.
· 
Cell differentiation and characterization
· Distribution, residual and homing at molecular scale

Platforms

Platforms

·LC-MS/MS PlatformSCIEX Triple Quad 5500、SCIEX Triple Quad 4500、SCIEX API 4000
· ELISA PlatformMoleculeDevices SpectraMax M5
· MSD PlatformMESO™ QUICKPLEX SQ120
· Simoa PlatformQuanterix SIMOA HD-X
· FACS PlatformBackan CytoFlex S