Approximately 70-90% of new chemical entities have solubility and bioavailability challenges that require special attention when it comes to optimizing their formulation approach. Spray-dried amorphous solid dispersions (SDDs) play a role in advancing the formulation of drugs with low solubility, helping to meet precise requirements to ensure bioavailability, stability, performance, and manufacturability.
Although the spray drying process is well-established and understood, it requires high levels of technical capability and operational excellence. Its key benefit, the formation of SDDs, results in higher surface areas compared to crystalline counterparts, which leads to better interactions between drug molecules and surrounding solvents, ultimately improving dissolution rates and enhancing product solubility.
Finding an appropriate stabilizing polymer is a critical first step, and Patheon’s Quadrant 2™ predicts optimal drug-polymer combinations and ratio options by assessing compatibility between functional groups (1). Once identified, the optimal drug-polymer system is dissolved in a solvent (2), and the solution is passed through an atomizer with a spray nozzle and drying gas (e.g. nitrogen), causing the solvent to evaporate and the droplets to dry into a powder (3). The spray-dried powder is sent through a secondary drying step where the solvent content is further reduced to meet ICH guidelines (4).
Thermo Fisher Scientific is an industry-leading CDMO with a depth and breadth of experience in optimizing the development and manufacturing of APIs, providing biopharma companies with spray drying capabilities from early development through commercial scale-up. To date, we have spray dried 120+ molecules, and our three global sites utilize state-of-the-art spray drying technologies.
Thanks to the comprehensive scope of our global spray drying facilities, Thermo Fisher Scientific is uniquely positioned to provide unparalleled scale-up capabilities, all within one network. From preclinical development to commercial manufacturing, we can provide spray drying services and solutions spanning from grams to tones. Additionally, we have the necessary infrastructure in place to safely spray dry both low- and highly-potent compounds alike, offering biopharma companies a range of capabilities for their APIs. By integrating API development and manufacturing, spray drying, and drug formulation under one roof, Thermo Fisher Scientific provides biopharma companies with end-to-end expertise and experience and continuous support at every step.
years of API development and manufacturing experience
molecules analyzed with Quadrant 2TM predictive modeling
spray dried molecules
Integration of API, spray drying, and drug product services
With four dedicated spray drying sites spanning the coasts of the United States plus England and Ireland, Thermo Fisher Scientific is well-positioned to provide industry-leading CDMO services to global biopharma companies seeking spray drying capabilities to enhance the solubility and bioavailability of their poorly water-soluble drugs. Explore key facts about each facility below and learn about the specific spray drying technologies that equip each location.
For process development and scale-up activities we utilize bench top Buchi B-290 and pilot-scale GEA Mobile MinorTM and Anhydro MS-150 equipment situated at our Bend, OR, USA site.
Further scale-up to commercial volumes is available at our facility in Florence, SC, containing commercial-scale Anhydro MS-400 and MS-1250 equipment.
Teams from the Bend, OR, and Florence, SC sites cooperate closely to support technology transfer activities and collaborate with clients to mitigate risk through the whole journey from molecule to medicine.
Article
A comprehensive approach to improving solubility and bioavailability: Spray drying
Read about critical components of spray drying in pharmaceutical manufacturing, considering scale-up and tech transfers, and the process from development through commercialization.
View ArticleFact Sheet
Spray drying services for API formulation challenges
This fact sheet explores Thermo Fisher Scientific’s solutions for poorly soluble APIs, including strategic spray drying solutions to overcome bioavailability and crystallization challenges.
Webinar
Conventional vs. unconventional spray drying strategies: development to commercialization
This webinar discusses strategic spray drying approaches to address bioavailability and crystallization challenges encountered with many of today’s promising new chemical entities.
View WebinarWebinar
Solving for solubility: A scale-up strategy for spray dried dispersions
Explore how to progress spray-dried dispersions from early formulation-screening through process development and scale-up for early clinical supplies to commercial manufacturing.
View Webinar