Spray drying offers a useful approach to address bioavailability challenges from development through to commercial scale. At Patheon, by Thermo Fisher Scientific, we have an effective process to manufacture amorphous solid dispersions to enhance bioavailability of poorly water-soluble molecules. This is applicable to a broad range of APIs. We offer a full range of scale manufacturing spray-dried material from Pre-Clinical to Commercial needs.
We have extensive expertise and experience in spray drying thermodynamics. We use bench top Buchi B-290, Anhydro 35, and larger-scale GEA Mobile Minor™ and Anhydro MS-150 equipment to support development scale. Further scale up to commercial is available at the newly constructed facility in Florence, SC, containing commercial scale Anhydro MS-400 and MS-1250 equipment. Aqueous spray drying is available from our Cork, Ireland site utilizing Niro PSD-2 equipment. Full analytical support plus QbD, PAT tools implementation, Design of Experiments and process validation are also available, and we have full drug product formulation and manufacturing capabilities. Teams from the Bend, OR and Florence sites co-operate closely to support technology transfer activities and collaborate with clients to mitigate risk through NDA submission and launch. In addition, process development and clinical scale spray drying will be available from our Milton Park, UK site starting in Q4 2019. Contact us to discuss whether spray drying may be a good fit for your project.
Download our whitepaper, “How Broadening the Analysis of Compound Factors Allows for Predictive Solubility Solutions”