Benefits of Solid State Chemistry
Author: Bahareh Khalili, PhD, Senior Group Leader, Solid State and Process Analytical R&D, Eurofins CDMO Alphora Inc.
Solid State research and development in pharmaceutical industry is as challenging as it is important and fascinating. Whether you are dealing with an active substance (API) bearing a complex polymorph landscape, difficult crystallization, challenging chiral resolution or other intricate physichochemical characteristics, our team of highly qualified scientists can help. Solid State Research and Development (SSRD) services at Eurofins CDMO Alphora Inc. support API and finished drug forms (FDF) developmental programs at any stage.
Utilizing state-of-the-art instrumentation, we apply High-Throughput Screening Technology (HTST) for expeditious discovery of new polymorphs, pharmaceutical salts, solvates and co-crystals to support API and FDF developments. This approach to solid form screening results in reduction of cost, manpower, time and requires minimal material quantities for these studies.
Dealing with difficult crystallizations, we apply a knowledge-based approach starting from solubility studies (high- and medium-throughput) followed by in-line monitored crystallizations coupled with solid state characterizations. Our finely engineered crystallization processes result in controlled polymorphic form and particle size while ensure high yield, superior purity, and process reproducibility.
For chiral resolution, we utilize a crystallization technique based on differences that diastereomers or diastereomeric salts of enantiomers exhibit in their physicochemical properties such as different solubility. Utilizing HTST, we can identify these differences in a variety of different solvents and choose best solvent and salt candidates to develop our diastereomeric crystallization.
When it comes to physicochemical characterizations, we select appropriate techniques from our extensive list of in-house instruments based on clients’ needs and regulatory requirements. Either you need to get to know your newly discovered API or to confirm specific characteristics of a well-known one, our SSRD team can provide data collection, interpretation, method development and qualification (cGMP). These characterizations include but not limited to PXRD, PSD, DVS, SEM, EDS, PLM, ATR-IR, DSC, TGA, NMR, RI, LOD, Raman spectroscopy and SCXRD.
Through the integration of synthetic process R&D, solid state R&D, pre-formulation and formulation development, we are providing a knowledge-based quality by design approach throughout the drug development and manufacturing, that supports client’s programs from pre-clinical to commercial.
