At Symeres, we’ve doubled our solid-state laboratory facilities in the Netherlands to add to our capacity and capabilities. The new lab space is dedicated to high-throughput screening and analytics, especially for the form-selection programs like salt, cocrystal and polymorph screening using automated crystallization platforms. The existing lab is now dedicated to physicochemical analyses (e.g., DSC, TGA, IR) and scale-up of the selected screening conditions.
“The new solid state lab represents a true milestone in the growth of Symeres,” states Gabriella Pizzuti, Director of Development in Weert. “This expansion positions our Solid State Center of Excellence in the market with renewed strength. The added capacity allows us to initiate a full crystallization screen each day, including high-throughput analytics by powder XRD and Raman spectroscopy. This means we can help more clients, faster, with more services.”
Solid-state studies are used for risk management in the selection of the physical form for the drug substance. In the past 10 years, our solid-state chemistry group has grown from just process support to now being able to conduct dedicated programs that cover crystallization, form selection, pre-formulation, and particle engineering. The continuous increase in customers and projects resulted in us expanding our dedicated screening laboratory and, as the department grew, so did our expertise. We can support projects from early phase discovery to large-scale process development. For early phase discovery, the first crystallization of the compound and initial salt formation can be studied. In the preclinical phase, we select the most stable polymorph and develop the best method to obtain this form. And at larger-scale process development, we optimize the isolation conditions as well as the particle size and shape.
The request for an early, conclusive selection of which form of the compound has the best chance to move forward is a critical part of our customers’ projects. Symeres combines process research and development with solid-state chemistry to provide an integrated approach to drug development. This integrated approach allows us to shorten the timelines and reduce amounts of material required. During this process, we consider the conditions needed for the crystallization process to be scalable and suitable for multikilo manufacturing as well as the needs for providing an API that matches the specific requirements for administration.
The new laboratory is the next step in our ambition to expand our crystallization and (pre-)formulation research capabilities, as an integral part of Symeres’ overall expansion plans for the future.
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