Bioanalytical Capabilities to Support DMPK Studies

The small and large molecule bioanalytical teams support DMPK, toxicology, and clinical groups with method development and validation, as well as sample analysis in all phases of drug discovery and development.

Our dedicated non-GLP and GLP bioanalysis teams provide the exact bioanalytical solution for the stage of your molecule, from fast turnaround assay discovery methods to formal validations and sample measurement, according to FDA, CFDA and EMA guidelines.

Our bioanalytical teams are close to the in vitro and in life groups, eliminating the need for sample shipment.

Bioanalysis for Small Molecular Drugs

Instrumentation

  • HPLC, UHPLC and high-throughput autosamplers
  • Shimadzu LC-20AD, Waters UPLC, Shimadzu Nexea UHPLC-30A
  • CTC/DLW, ADDA, MPXTM-2/Shimadzu Nexera UHPLC-30A
  • First-class triple quadrupole and high-resolution MS systems
  • Sciex Triple Quad 6500 plus, 6500, 5500, 4000, Shimadzu LC-MS-8060, and Thermo Q ExactiveTM Plus
  • Nine dedicated high-throughput LC-MS/MS for in vitro biology and in vitro ADME
  • 26 LC-MS/MS systems for in vivo bioanalysis support for screening, lead optimization and pre-IND filing

Capacity and Turnaround Time

  • In vitro: Timeline <1 day (>40,000 samples per week)
  • In vivo: Timeline <3 days (>10,000 samples per week)
  • Timeline of bioanalytical studies required for IND application <14 days (method validation according to FDA and CFAD guidance)

Bioanalysis for Large Molecule Drugs

  • Over 100 experienced scientistis, 8000 m2 / 20,000 sq.ft of laboratory space
  • Bioanalysis of antibodies, recombinant proteins, peptides fusion protein and antibody drug conjugates, vaccine for PK

Validated Methods

  • Immunogenicity (ADA and neutralizing antibodies)
  • PK
  • Single and multiplex biomarkers
  • Receptoroccupancy
  • Immunophenotyping

Instrumentation

  • 2× Luminex® 200TM, 2× MSD, 2× FCM (FACSCanto II, Fortessa)
  • 9× ELISA plate reader, 1× Gyrolab XP, 2× Gamma Counter
  • 1× Alpha-LISA
  • 2× Tecan EVO automated ELISA workstation
  • 2× Hamilton Microlab Star workstation
  • 7× Bio-Tek plate washer