(500h) Amorphous Solid Dispersions By Spray Drying: From Early Formulation to Commercial Lifecycle Management

We will cover the basics of the Amorphous Solid Dispersions (ASD) platform, and the relevance of spray drying in establishing ASD as a reliable platform at the industrial scale. We will also provide historical background from the last 20 years where the platform was adopted and became mature, showing how the ASD platform has been consistently behind a significant number of NDAs per year. Then, the role of a CDMO will be discussed in terms of democratization of the ASD platform, making it accessible to the broader Pharma industry, for which the business case for relatively large CAPEX investment is not easily justifiable considering limited pipelines (which may fail during clinical development). We will further guide the audience through the complete journey of ASDs manufactured by spray drying, starting from the early formulation stage to process development and scale-up, and through commercial reality and lifecycle management:

• Early Formulation: Details will be provided on how to select the right formulation for a drug candidate using a screening methodology which is run through an automated high-throughput system that was developed using years of experience with formulation of ASDs. It will be provided an understanding of the methodology, the evaluation process and the studies typically utilized, as well as key information needed to make a formal assessment of the best ASD candidates.
• Process Development and Scale-up: There will be a description of the best practices to transition ASD formulations developed in the laboratory into a reliable industrial process, based upon proven methodologies for process development and scale-up, guaranteeing lean and material sparing approaches. We will cover industry standard QbD principles, mathematical models and process development methodologies that rely on development and manufacturing experience. Existing lab assets will be presented, including a customized spray dryer that can mimic large scale powder properties. Also, it will be shown how to accelerate drug development by accessing a database of spray drying conditions (solvents, polymers, and spray drying scales) to establish a design space for commercial manufacturing.
• Commercial Life-Cycle Management: An overview will be provided on how to apply Quality Risk Management through product lifecycle, and conduct Process Performance Qualification and Validation, and Continued Process Verification relying on statistical process control. The implementation of post-approval changes and continuous improvement will be detailed, focusing on yield and productivity, supply chain security, scale-up as a means to meet demand, all of which will be complemented with case studies.

Finally, we will cover opportunities for further intensification of the ASD platform, namely by improving its efficiency (both production and equipment changeover), addressing sustainability and supply chain challenges (e.g. strategies to minimize the use of specific solvents), and supporting early phase drug development with new offerings in that space.