Events such as the coronavirus pandemic make us aware that access to innovative, affordable and safe medicines is one of the challenges of our time for the rapidly growing world population. From its location in Berlin-Adlershof, Chromicent GmbH supports the pharmaceutical industry in the development of pharmaceuticals to combat and treat infections with the SARS CoV-2 coronavirus.
Dr. Alexander H. Schmidt, Managing Director and Head of the Quality Unit at Chromicent GmbH says: “With all our efforts in vaccine development, we have to keep in mind that a vaccine cannot help an immediately sick person – it must be administered preventively. That is why it is just as important to drive the development of new, innovative drugs to fight the virus. The method development platform of Chromicent GmbH accelerates exactly this development of pharmaceuticals considerably. We succeed in this by integrating quality-by-design principles while minimizing the risks. “
In contrast to the empirically based methods used in traditional manufacturing and quality control, quality-by-design is a scientifically risk-based approach. An approach that is designed to integrate and ensure quality in a drug right from the start. On the one hand, this means significantly reducing development times and, on the other hand, preventing disruptions in the manufacture or quality of the pharmaceuticals.
As Mijo Stanic, second managing director and technical director, notes, that Chromicent uses the revolutionary method development and optimization software DryLab® from the Berlin Molnar Institute and on the leading chromatography data software (CDS) Empower 3 from Waters Corp. By combining the two software programs, it is possible to drastically shorten the method development times, e.g. by optimizing the use of complex chromatographic systems and at the same time determining the most robust method conditions. By fully complying with the official requirements (EMA, FDA) for Method LifeCycle Management (MLCM), the quality of the results is significantly improved and ultimately patient safety is guaranteed.
The combination of innovative thinking, scientific expertise and many years of experience make the interdisciplinary team at Chromicent GmbH the partner for all aspects of Method LifeCycle Management in drug development.
“Chromicent GmbH, with its method development platform, is ready in this difficult time to provide the research-based pharmaceutical industry with comprehensive support in its most urgent needs – and therefore ultimately for the patients, to ensures fast, continuous and secure access to innovative drugs”, promise the managing directors.