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The Bioanalytical Laboratory of the Pharmacy

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Partners in bioanalysis

The strategic location of the GLP-certified laboratory close to the clinical research units of the Netherlands Cancer Institute facilitates the support of clinical studies with anticancer drugs with time-critical samples to be analysed (rapid turnaround times for dose escalation studies and therapeutic drug monitoring) and of mass balance studies preventing the shipment of radioactive samples. The co-located clinical research units enables innovative working collaboration with clinicians, efficient analysis and faster progress of clinical studies leading to a reduction in the costs.

Know-how

Our bioanalytical group is comprised of specialists with over 25 years of experience in bioanalysis, cooperation with sponsors and clinics. Our employees are specialised in the development of bioanalytical methods for complex anticancer drugs. We offer validated methods for the quantification of anticancer drugs that are ready for use, including ultra-sensitive methods down to lower limits of quantification of pg/mL in body fluids and methods for the quantification of anticancer drugs in other matrices (PBMCs, tumour tissues and DNA).

Communication

Each project has an assigned bioanalytical study director and this scientist is in the lead of the technicians dedicated to the project. The bioanalytical study director keeps the sponsor informed on a regular basis according to the requirements of the sponsor. The longstanding staff experience ensures business continuity and efficiency.

Recognized quality

Validation criteria follow guidelines from the FDA and EMA. All validations are tailored for the support of specific studies. Our dedicated facility is GLP compliant since 1999 and periodically inspected by the authorities. We have an independent QA group responsible for facility, process and study audits and GLP training.

Technologies

We are committed to offer our sponsors the latest technologies on ultra-(high) performance liquid chromatography coupled to triple quadrupole mass spectrometers and orbi-trap mass spectrometers. With our state-of-the art equipment we are able to support microdosing studies and mass balance studies. We have a licence for the analysis of radio labelled compounds and at our facility Liquid Scintillation Counters are available for 14C, 3H and 125I. For low radioactive, fractionated mass balance study samples (radioprofiling), a Liquid Scintillation Counter is operating at the Bioanalytical laboratory.

Quantitative ultrasensitive analysis of metal-based drugs can be performed using ICP-MS.

We provide bioanalytical capabilities for Phase I-IV trials and pre-clinical studies.

Contact information

Professor Dr. Jos Beijnen (j.beijnen@nki.nl)

Dr. Hilde Rosing (h.rosing@nki.nl)

Directions

The Bioanalytical Laboratory of the Netherlands Cancer Institute is part of the Pharmacy Division (Department of Pharmacy & Pharmacology) and is currently located in

MC Slotervaart
(2nd floor, B-wing)
Louwesweg 6
1066 EC Amsterdam
The Netherlands

Further information

Services and Support
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Services and Support

Services

 

  • Development, validation and implementation of bioanalytical methods
  • Transfer and cross validation of bioanalytical methods
  • Bioanalysis of samples from clinical studies and pre-clinical studies
  • Long-term stability evaluations
  • Preparation of Bioanalytical Reports and Validation Reports (to standard templates or customized)
  • Electronic transfer of data according to the specifications of the sponsor

 Support of clinical and preclinical studies

 

  • Toxicology studies
  • Early to late phase clinical trials (phase I - IV)
  • Mass Balance and Metabolite Profiling Studies
  • Microdosing studies
  • Bioavailability studies
  • Bioequivalence studies
  • Food effect studies
  • Drug interaction studies
  • Therapeutic drug monitoring
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Equipment and Technologies
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Equipment and Technologies

 

  • Triple quadrupole MS instruments
  • Ion trap and orbitrap MS instruments
  • Induced Couple Plasma MS instrument
  • Liquid Scintillation Counters
  • U(H)PLC technology
  • Classical HPLC combined with UV and fluorescence detectors
  • Gas Chromatography
  • Chiral separations (LC and GC)
  • Dried Blood Spots/VAMS analysis
  • Protein Binding
  • Chemical Derivatization
  • Multi component analysis
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Quality Assurance
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Quality Assurance


Validation criteria follow guidelines from the FDA and EMA. All validations are tailored for the support of specific studies. Our dedicated facility is GLP compliant since 1999 and periodically inspected by the authorities. For our most recent endorsement of compliance click here. We have an independent QA group responsible for facility, process and study audits and GLP training.

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Recent Publications
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Recent Publications


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for a selection of the publication.

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People working at the Bioanalytical Laboratory
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People working at the Bioanalytical Laboratory


Hilde Rosing, teamleader

I have over thirty years analytical and bioanalytical experience in the Quality Control (QC) and Research & Development (R&D). My experience has covered laboratory and project management, analytical assay development and validation studies to support pharmacokinetic studies (Phase I, II, III), bioavailability studies, mass balance studies, stability testing and R&D projects.

During this period I have gained experience in managing analytical contract projects. As study director I have been directly involved in discussion with national and international sponsors.
From 2000, I have been acting as co-promotor for eight PhD students. I am (co)-author of more than 200 publications.

Telephone: +3120 512 4476

E-mail address: h.rosing@nki.nl

LinkedIn

Matthijs Tibben, Study Director

After finishing my Bachelor in Analytical Chemistry, I started at the NKI as Research Technician on a PhD project in November 1997. In 2001 I started as a Bioanalytical Study Director for several projects within the laboratory. My experience covers laboratory and project management, analytical assay development and validation, analytical support of pharmacokinetic studies, mass balance studies, stability testing and R&D projects, all in a GLP regulated environment. My analytical expertise covers bioanalytical sample pre-treatment, HPLC separation, ICP-MS and (LC-)MS detection. I am (co-) author of more than 30 publications.

Telephone: +3120 512 4627

E-mail address: m.tibben@nki.nl

LinkedIn

Luc Lucas, Study Director

As bioanalytical study director I am responsible for the planning, quality, interpretation and reporting of the results of different projects (bioanalytical method development, validation, analysis of pre-clinical and clinical samples, mass balance studies etc.). As study director I have been in contact with national and international sponsors. Since 1999 our lab is operating according to the OECD guidelines on Good Laboratory Practice and I contribute to the maintenance and improvement of our quality system.

Telephone: +3120 512 4180

E-mail address: l.lucas@nki.nl

Bas Thijssen, Study director

I am working as a bioanalytical study director in the laboratory.  I have experience in coordinating the bioanalysis for both clinical and pre-clinical studies, assay development and validation and stability testing in a GLP environment. As former research technician I still have feeling and experience with all the techniques we are currently using for our sample pre-treatment and measurements (mostly LC-MS).

Telephone: +3120 512 4180

E-mail address: bas.thijssen@nki.nl

Michel Hillebrand, Senior MS Technician

In 1982 I started as a technician at the NKI. At first in the division of Experimental Therapy, later on the divisions Chemical Carcinogenesis and Molecular Carcinogenesis. In 1997 I joint the Department of Pharmacy & Pharmacology at the Slotervaart Hospital/NKI where my main work consisted of analytical method development and validation for the support of clinical trials. At this moment I am responsible for the continuity and coordination of work concerning Mass Spectrometry in the Laboratory of the Department. This includes coaching and guiding PhD students, giving technical support and training, method development and maintenance.   

Telephone number: +3120 512 4180

E-mail address: m.hillebrand@nki.nl

LinkedIn

Niels de Vries, Technician

After finishing my Bachelor in Analytical Chemistry in the end of 2011 (Inholland, University of Applied Sciences) I started working as a research analyst in the group of Prof. dr. J. H. Beijnen. During my study I did internships at the University of Amsterdam in the group of Prof. dr. A. Brouwer where I developed an LC-UV method, and at the Slotervaarthospital in the group of Prof. dr. J. H. Beijnen where I developed an ICP-MS method.

As a research analyst at the Bioanalytical Laboratory of the Pharmacy I work within the GLP regulations. My main focus is the development, validation and implementation of methods using LC-MS/MS, UPLC-MS/MS and ICP-MS within the EMA and FDA guidelines. These include bioanalytical methods to quantify anticancer drugs such as tyrosine kinase inhibitors, platinum-based anti-cancer drugs and capecitabine and its metabolites. In addition I also perform preventive maintenance on several mass spectrometers to guarantee the quality of the analysis.

Telephone number: +3120 512 4477

E-mail address: ni.d.vries@nki.nl

LinkedIn

Abadi Gebretensae, Technician

In 2004 I started working as a technician in the Department of Pharmacy & Pharmacology. I am involved in the development and validation of bioanalytical methods for the quantification of anti-cancer drugs using (UP)LC-MS/MS and the application of these methods to support clinical studies according to the OECD principles on Good Laboratory Practice (GLP).

I gained experience in extraction techniques such as Protein Precipitation (PP), Solid phase Extraction (SPE), and Liquid-Liquid extraction (LL). Furthermore I am involved in the execution of preventive and curative maintenance on various instruments in the laboratory, such as HPLC systems and mass spectrometers.

I am responsible for the planning of the maintenance or performance verification of all instruments in the laboratory, checking if the test results meet the specifications to ensure proper performance.

Telephone number: +31641675178

Email address: a.gebretensae@nki.nl

LinkedIn

Anke Kip, PhD student

In 2011 I finished my masters Drug Innovation at Utrecht University after which I started my PhD project at the department of pharmacy & pharmacology. My research project focusses on the pharmacokinetic (PK) analyses of drugs against Leishmaniasis, supported by bioanalytical method validation. Currently, I am working on population pharmacokinetic models, to gain more insight on the exposure-response relationship of these drugs.

Telephone: +3120 512 4073

E-mail adres: a.kip@nki.nl

Linkedin

Remy Verheijen, PhD student

In 2013, I graduated from the University of Groningen with a Msc in Pharmacy. Thereafter I started working on my PhD thesis at the department of Pharmacy & Pharmacology of the NKI. The focus of my thesis is on the application of bioanalytical methods and pharmacokinetics in clinical trials of molecularly targeted anti-cancer drugs, with the goal of optimizing and personalizing the treatment of cancer patients.

Telephone: +3120 512 4665

E-mail address: r.verheijen@nki.nl

Linkedin

Lotte van Andel, PhD student

After finishing my Bachelor's Degree at University College Roosevelt and my Master's Degree in Forensic Analysis at Kingston University London, I started my PhD at the Bioanalytical Laboratory of the Pharmacy of the NKI. Under supervision of Prof. J. Schellens and Prof. J.H. Beijnen, I'm currently working on two mass balance studies of two novel compounds in phase II/III clinical trials. The main focus of my research is the development of bioanalytical methods to support pharmacological clinical trials and to investigate the absorption, distribution, metabolism and elimination of anticancer compounds.

Telephone number: +3120 512 4073

e-mail address: l.v.andel@nki.nl

Linkedin

Maikel Herbrink, PhD student

I graduated from the University of Groningen in Pharmacy with a technical specialisation. After obtaining my master's degree I started as a PhD student under the supervision  of prof. Dr. Beijnen and Dr. Nuijen. The research I am involved in focusses on the development  and improvement of anti cancer drug formulations and the clinical assessment thereof.  My projects include formulation development, quality control, clinical trials and bioanalysis.

Telephone number: +31 20 512 5008

E-mail: m.herbrink@nki.nl

LinkedIn 

Jeroen Roosendaal, PhD student

After finishing my Masters in Pharmacy in 2015 (Utrecht University) I started working as a PhD student in the group of Prof. dr. J.H. Beijnen. My research is mainly focused on phase I mass balance studies in oncology. Mass balance studies investigate the absorption, distribution, metabolism and excretion (ADME) of radiolabeled drugs following a single administration to humans.

Telephone: +3120 512 4738

E-mail address: j.roosendaal@nki.nl

Linkedin 

Merel van Nuland, PhD student

After finishing my masters in pharmacy at the end of 2015, I started a PhD at the department of pharmacy & pharmacology, Amsterdam. The main focus of my research is on the development of bioanalytical methods in oncology. These assays will be used in clinical drug development and support of treatment opitimization therapeutic drug monitoring.

Telephone: +3120 512 4073

E-mail address: n.v.nuland@nki.nl

Linkedin

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