Combining strong scientific and regulatory knowledge with state-of-the art technologies, the ERBC’s analytical chemistry team conducts feasibility studies and set-up and validates new testing methods. All studies are performed in a GLP facility and clinical study samples are managed in agreement with GCP requirements (FDA and EMA guidelines).

Preclinical and clinical samples analysis

• Including logistical services

Method development/transfer and validation

• Solid phase extraction, liquid/liquid extraction, protein precipitation plate, ultra-centrifugation and micro dialysis

Microsampling plasma/blood

• Dried blood spot, volumetric blood micro extraction (VAMS), capillary micro sampling

Formulation and stability analysis

• Solutions, suspensions, diet

PK/TK samples analysis

• All biological fluids and tissues

Metabolite stability assays and identification

• High Resolution Mass Spectrometry

Oxidative metabolism

Drug- Drug Interaction studies

• Cytochrome P450 direct inhibition
• Cytochrome P450 time dependent inhibition
• Cytochrome P450 induction

Protein binding studies

Antibody studies

• PK/TK studies
• DAR characterization of ADC

Skin absorption studies (OECD 428)

Analysis of Veterinary Residues in Animal Tissues

• Solid phase and liquid-liquid extraction, protein precipitation plate
  
  
  

Instrumentation (GLP and GXP compliant):

• High Resolution Triple TOF mass spectrometers with MicroLC (API 6600 plus, API 5600 plus)
• Low Resolution Triple Quadrupole mass spectrometers with MicroLC (2 API 2000, API 4000, API 4000QTrap, API 5500 QTrap)
• HPLC equipped with UV, fluorimeter and light scattering detectors
• UPLC equipped with UV and fluorimeter detectors
• UV/Vis spectrophotometer
• GC equipped with FID, NPD, ECD and MS detector