New opportunities for the evaluation of bio-distribution and pharmacokinetic studies of therapeutic products containing metal ions

Theodosia Tsolakou, chemist and principal investigator, Eurofins Biopharma Product Testing Denmark, Theodosiatsolakou@eurofins.dk

Several drugs containing metal ions are used in the treatment of severe medical conditions and illnesses. To determine drug dose, absorption, distribution, metabolism, and excretion of the metal ions for in vivo and clinical samples, new analytical technologies and tools have been developed for preclinical and clinical evaluation. The technologies allow for an evaluation of intended and unintended accumulation of metal ions in specific organs and body fluids.

With more than 15 years of experience developing and executing methods for metals analysis, Eurofins BioPharma Product Testing offers the complete range of metal testing services for preclinical and clinical samples, including method development and validation according to EMA or ICH guidelines, as well as testing of whole blood, serum, plasma, urine, tissues such as kidneys, heart, liver, spleen, bone marrow, etc.

Able to detect even minor differences in metal levels for specific samples, Eurofins BioPharma Product Testing can detect down to the ppb level, due to extensive possibilities for sample pre-treatment by microwaves and other sample preparation techniques in a specially designed high pressure room to safeguard samples from contaminating air particles.

In collaboration, in vivo research has been set up at partner lab, BSL BIOSERVICE in Munich, and samples are subsequently analysed at the Eurofins Biopharma Product Testing site in Copenhagen. BSL BIOSERVICE specialises in preclinical safety testing for drug candidates, including bio-distribution and pharmacokinetic studies. Eurofins Biopharma Product Testing Denmark is a Competence Centre for low level trace metal testing in the Biopharma Product Testing group and obtained GLP approval in November 2015 to support the regulatory requirements in pharmacokinetic studies.

Eurofins BioPharma Product Testing can help in the planning and execution of sample handling, selection of instrumentation and general instrument performance advice, optimised for specific testing needs. Eurofins BioPharma Product Testing’s regulatory experience enables analysts to ask the right questions and determine the most appropriate testing approach, delivering service that meets client needs.

For more information visit: www.Eurofins.dk/ media/1229997/eurofins-metals-testing-in-clinical-andpreclinical- samples.pdf