Seventy percent of drugs in development have solubility issues, requiring special attention to formulation. Spray drying offers a useful approach to address bioavailability challenges from development through to commercial scale. With competitive options for API outsourcing in all geographical regions, it can be difficult to choose the right partner for your project, regardless of its complexity.
Thermo Fisher Scientific offers the expertise and capabilities to partner with pharmaceutical companies of all sizes and in all stages of development. 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. For process development and scale up activities we utilize bench top Buchi B-290, Anhydro 35, and larger-scale GEA Mobile Minor™ and Anhydro MS-150 equipment situated at our Bend, OR and Milton Park, UK sites. Further scale up to commercial volumes is available at the newly constructed facility in Florence, SC, containing commercial scale Anhydro MS-400 and MS-1250 (2021) equipment. Aqueous spray drying for late phase development and commercial scale is available from our Cork, Ireland site utilizing GEA PSD-3 equipment. Full analytical support plus QbD, PAT tools implementation, Design of Experiments and process validation are also available. Teams from the Bend, OR, Milton Park, UK and Florence, SC sites co-operate closely to support technology transfer activities and collaborate with clients to mitigate risk through process development, NDA submission and launch.
In addition, we can offer API manufacture and drug product development and commercial supply services with your spray drying needs to deliver an integrated offering to solve your challenges and move your product to the next milestone. Contact us to discuss whether spray drying may be a good fit for your project.
Watch this webinar to learn more about our spray drying capabilities from development to commercial scale.