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Analytical Chemistry Lab

 

The Analytical Chemistry Lab develops or adopts validated methods for the quantification of drugs, their metabolites, and endogenous compounds in biological samples (isolated cells, body fluids, or tissue specimens of animal or human origin) to address pharmacokinetic, pathophysiological, and toxicological questions. Particular emphasis is put on efficient development processes and on the adherence to international validation standards (e.g. FDA- and EMA-approved criteria).

 

Staff

Head: 

Jürgen Burhenne, PhD
Scientific Staff:

Margaux Fresnais, PhD
Max Sauter
Dr. rer. net. Philip Uhl

Technical Staff:Andrea Deschlmayr
Kevin Jansen
Magdalena Longo

Doctoral Students:

Yeliz Enderle, Pharmacist
Kathrin Foerster, Pharmacist
Manuela Vay, Pharmacist

 

Therapeutic Drug Monitoring (TDM)

The Department analyzes voriconazole plasma concentrations for the University Hospital and for external clients. Quality assurance involves participation in interlaboratory comparison programmes.

 

Initiates file downloadTDM Voriconazol (Vfend®) - TDM order form

 

In support of the Heidelberg Reference Lab for Pulmonary Arterial Hypertension (PAH), the department analyses patient samples for TDM for ambrisentan, bosentan, macitentan, sildenafil, tadalafil.

 

TDM Pulmonary Arterial Hypertension -TDM order form

 

The Department analyzes direct oral anticoagulant (dabigatran, rivaroxaban, apixaban, and edoxaban) plasma concentrations for the University Hospital and for external clients.

 

 Initiates file downloadTDM Direct Oral Anticoagulant - TDM order form

 

Research topics

  • Quantification of drugs in compartments at the site of action to establish concentration-response relationships
  • Quantification of different drugs (e.g. chemotherapeutics, antimycotics, endothelin receptor anatagonists) and their metabolites by LC/MS/MS in plasma, urine, cells, and cell supernatants (from in-vitro studies), and in any biologic matrix of human or animal origin
  • Development, validation, and application of ultrasensitive quantification methods for substrates of cytochrome P450 isozymes  (e.g. CYP3A4) and ABC transport proteins
  • Development of new quantification methods, optimization, and automatization of sample processing techniques.

 

Methods and equipment

Within the research topics, different analytical and extraction techniques will be applied. These methods are based on chromatography and mass spectrometry, and various processing techniques, including protein precipitation, solid phase extraction, and liquid/liquid extraction.

Besides others, the following analyses are frequently performed in clinical trials:

  • Antibiotics
  • Antimykotics
  • Antiviral drugs
  • Chemotherapeutic drugs
  • Endothelin Receptor Antagonists (ERA)
  • CYP3A4 phenotyping

Instrumental analysis

    • nanoflowLC/MS/MS Waters Xevo G2-XS QToF
    • nanoflowLC/MS/MS Waters Xevo TQ-S
    • UPLC/MS/MS Waters Xevo TQ-S
    • UPLC/MS/MS Waters TQD
    • LC/MS/MS Finnigan TSQ 7000
    • LC/MS/MS AB Sciex API 4000
    • HPLC Thermo (DAD/Fl)

      Lab standards

      • ISO 9001:2008 certification
      • S1 security for handling genetically engineered organisms
      • SOPs for processes, equipment, and methods
      • Bioanalytical Method Validation according to the Guidelines of FDA (Guidance for Industry, Bioanalytical Method Validation, Mai 2001 and EMA Guideline on Bioanalytical Method Validation, February 2012)

       

      Cooperations

       

       

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