Fabia Gozzo from Excelsus Structural Solutions – Switzerland & Belgium will talk about:
"The development of Synchrotron-XRPD analytical services to best meet the needs of the pharmaceutical industry"
Excelsus Structural Solutions has optimized the Synchrotron-XRPD analytical technique to be able to detect and quantify pharmaceutical crystalline forms (polymorphs) at unprecedented low levels (0.01% in weight). It has also succeeded in quantifying mixtures of poorly crystalline and amorphous forms and continues to further develop this emerging methodology in collaboration with academic groups. These technical achievements have enabled Excelsus to develop powerful tools for the characterization of Active Pharmaceutical Ingredients (API) and formulated Drug Products.
In this webinar, we discuss the key role that these tools can play throughout the whole life-cycle of pharmaceuticals, from development to commercial production, including in the field of IP protection. Different polymorphic forms of an API can indeed have different therapeutic activities; a tight control of them is therefore key to guarantee safety and efficacy to patients and thus to comply with the latest regulatory requirements.
We also present the unique business model developed by Excelsus Structural Solutions, to make complex Synchrotron-XRPD techniques readily available to the pharmaceutical industry for both “routine” measurements and investigational studies. We discuss the key services and ways of working we have developed to best meet the needs of our customers, such as confidentiality, flexibility and speed, stringent deadlines, full traceability of samples and data, as well as the implementation of written standard operating procedures (SOPs) and other documents, to ensure a high quality of our services.