Selecting the optimal particle characteristics for your API is a critical part of bringing it to market. It is key to controlling costs, overcoming challenges, and ensuring your product performs as it should. But achieving the ideal version of an API can be a long and complex process, requiring extensive solid form investigation, crystallisation work, and even particle size manipulation to enhance API solubility, bioavailability, and efficacy. The right outsourced partner can streamline this process by delivering robust material science solutions as a natural extension of their services in API development and manufacturing.
At Sterling, we have what it takes to support all of your material science requirements in-house. Our world-class Material Science Centre is home to a fully-equipped laboratory for solid form development investigations and analysis, four state-of-the-art milling suites, and CCTV controlled areas that enable you to safely view operations no matter where you are.
But our facilities are only the beginning… Through four interconnected areas of solid form investigation, including salt/cocrystal screening, polymorph screening, pre-formulation evaluation, and crystallisation, and a full range of supporting analytical techniques. Our expert solid state team can help you identify the most stable and effective version of your API, while maintaining full transparency and close collaboration along the way.
When a smaller particle size distribution is required, we work with you to develop and execute a precise particle size reduction programme in house. Through state of the art suites of milling and micronisation equipment, which are housed in an ISO Class 8 cleanrooms equipped with access control, CCTV monitoring, temperature control, and humidity monitoring we can handle small-scale milling to large commercial batches. Capable of achieving a particle size down to 30 microns through milling or .25 microns through micronisation, we ensure your API’s suitability for drug product formulation.
Navigating your project’s material science requirements can be a challenge. But the right partner makes all the difference.