Service Overview

Nuvisan will support you with DMPK/ADME services throughout the discovery and development phases.

Discovery 
In vitro and (rapid turnover) in vivo studies to support decision making in medicinal chemistry and discovery pharmacology. Bioanalytical method development

Early Development 
Tailor-made “phase 0” in vitro and in vivo packages, i.e., in vitro metabolism, CYP interactions, absorption, distribution, and transport, PK/ADME in rodents and non-rodents. Contribution to regulatory documents (IB, IMPD, IND). Bioanalytical method development and validation.

Development
ADME studies (radioactive and unlabeled) in vitro and in relevant rodent and non-rodent species (including NHP). In house radio- and stable isotope labeling. State-of-the-art radio analysis and metabolite identification. Regulatory drug-drug interaction studies (in vitro and in vivo in preclinical species) including assessment of clinical relevance. Consulting and program management by experienced pharmaceutical industry scientists.

Your Benefit

  • Experienced, pharmaceutical industry-trained experts (scientists and lab technicians)
  • Routine to provide high turnover of in vivo PK studies in a project based drug discovery environment, tailor-made, high quality in vitro and in vivo studies in drug development
  • GLP certification accreditation since 1990
  • Broad DMPK expertise under one roof, strong network to experts in pharmaceutical industry and academia
  • Capabilities and expertise for NCE and NBE bioanalysis
  • Integrated services from drug discovery up to the clinical phases

Quality Standards

  • GLP certification since 1990
  • AAALAC accreditation since 2015
  • Licensed to work with radioactivity (14C, 3H)
  • S1 License to work with genetically modified organisms

Equipment Highlights

  • Waters Acquity UPLC systems
  • Thermo LTQ Orbitrap XL and AB Sciex triple quad and Qtrap mass spectrometers
  • Hidex and Perkin Elmer Liquid Scintillation Counters
  • Radioactive Profiling: HPLC with radio-detector, UPLC with fraction collection and TopCount analysis
  • Leica CM3600 Cryomacrocut, Fuji Bas 5000
  • Bruker NMR 400 UltraShield

Facilities

  • Located near Munich, 45 mins from Munich airport
  • 1200 sqm of analytical, biochemical, and synthetic chemistry laboratory space
  • 1150 sqm of animal facilities, including an outside exercise area for dogs, and two large gang cage units for NHPs

Contact

Business Development
Please send us an Email!

 

 

Dr. Sylvie Bruchmann
Vice President