Approximately 80% of drugs in clinical development have solubility issues requiring special attention to drug product formulation and manufacturing. Spray drying offers an effective solution to address solubility and subsequent bioavailability challenges. Thermo Fisher Scientific offers capabilities and expertise for spray drying applicable to a broad range of API’s. From process development, scale up through clinical development to commercialization, we can partner with pharmaceutical companies across all sectors. Our extensive expertise in spray drying thermodynamics will accelerate your scientific idea to approved medicine.
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 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, solid state chemistry 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 offer solutions for your project.
Watch this webinar to learn more about our spray drying capabilities from development to commercial scale.