Bioanalysis

In recent years companies have placed increasing focus on bioanalysis for its important role in the early phase of R&D. Medicilon’s Bioanalysis Department has a professional scientific research team with analysis laboratories equipped with advanced instruments. In the context of information management, we are compliant with the standards of FDA and NMPA GLP. We utilise pharmacokinetics, toxicokinetics, pharmacodynamics, immunogenicity and bioequivalence data, so as to provide our clients with services that facilitate the preclinical and clinical selection and development of small molecule drugs, biological preparations, vaccines and biomarkers.

• Small Molecule Bio-analytical PlatformBiotechnology Drug Analysis PlatformSupported IND declaration for over 100 domestic and foreign new drugsNMPA GLP certificationUS FDA GLP listed

  Software systems: protecting sample management

  Watson LIMS Laboratory Information Management SoftwareSensaTronics Temperature Monitoring System

  

Bioanalytical Platform

• Nucleic Acid Drugs
  PK/TK AnalysisImmunogenicity analysisPD or TOX-related cytokines and biomarkers (Cytokine & Biomarker)
• ADC Drugs
  Medicilon started ADC drug non-clinical studies in 2014 and has contributed to the clinical approval of several ADC drugs. In 2022, Medicilon has 13 ADC studies approved by NMPA and/or FDA.
• Metabolite Identification
  In vitro incubation metabolite identificationReactive metabolite identificationIn vivo metabolite identification