Dirk Evers, Engineer (Dipl.-Ing. [FH]), Co-Founder and Head of Analytical Development

Dirk Evers leads the analytical development of RaDes GmbH. He is a chemical engineer and has more than 25 years of experience in pharmaceutical analytics, in particular of semi-solid and liquid dosage forms. For these, he has provided analytical support for a variety of development and market products.

His work focuses on the development and validation of analytical methods for active pharmaceutical ingredients, their degradation products, and excipients, including the associated extraction processes. He has successfully established numerous new analytical technologies, in particular various mass spectrometric methods, for the determination of structural information of unknown degradation products. He also has rich experience in trouble shooting.

In addition, he has made important contributions to excipient characterization, in particular to innovative methods of polysorbate analysis in biopharmaceutical formulations, which are also described in several publications. These methods can help to optimize protein formulation in terms of stability and safety.

He developed methods to carry out precise calculations of the expected shelf lives based on quantification of degradation products. The predictions have proven to be very reliable and have contributed to the targeted optimization of many products. He has in-depth knowledge of statistical methods for data evaluation and for DoE-based optimization of chromatographic methods.

Prior to co-founding RaDes, Dirk held the position of Leader Analytical Science and Preformulation at Almirall Hermal. He also has extensive knowledge of regulatory requirements for pharmaceuticals (GMP, ICH).