Importance of Bioanalytics for Biopharmaceuticals


Published 02 July 2019



Szilard Kamondi
Senior Bioanalytical Consultant, Kamondi Bioanalytical Consultancy GmbH

Bioanalysis plays a critical role in drug development, is essential to the discovery, development and regulatory approval of new medicines. Employed for the quantitative determination of drugs and endogenous compounds, qualitative and/or quasi-quantitative characterisation of immune responses in biological fluids, it is key to modern pharmacokinetics, pharmacodynamics, and determining drug safety profiles and efficacy potentials.

Bioanalysts’ goal is to consistently deliver accurate and reliable data according to rigorous scientific and regulatory expectations, ensuring the success of the non-clinical and clinical programs. Science and regulations go hand in hand, good practices may not improve any poor sciences but make good sciences better as to ensure the quality, integrity and reconstructability of data.

The advances in technology that are in accordance with the challenges by new therapeutic modalities enable the development of robust assays to meet increased requirements across a wide range of large molecule biotherapeutics.

This course will provide useful training for bioanalytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories and departments. Participants will learn through lectures and case studies how to develop and implement strategies for routine, non-routine and standard bioanalytical methods in the world of pharmacokinetics, immunogenicity, and fluid biomarkers.