Spray drying offers a useful approach to address bioavailability challenges from development through to commercial scale. At Patheon, part of 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 (with Commercial services available from May 2019).
We have extensive expertise and experience in spray drying thermodynamics. Our facility in Bend, OR, uses bench top Buchi B-290 and larger-scale GEA Mobile Minor™ and Anhydro MS-150 equipment to support development scale and small-scale commercial needs. Further scale up to commercial scale will be available from May 2019 at the newly constructed facility in Florence, SC, containing commercial scale Anhydro MS-400 and MS-1250 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 and Florence sites co-operate closely to support technology transfer activities and collaborate with clients to mitigate risk through NDA submission and launch.
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”