Crucial Considerations for Clinic-Ready ASD Product Design - Part 1

Formulation development of ASDs focuses on polymer selection, the ratio of drug to polymer, and the design of the ASD particles to develop a system that is physically stable while also demonstrating optimal performance. Performance of an ASD is defined by enhancement in bioavailability which is driven by both supersaturation of dissolved drug and the formation of drug-polymer colloids. In this presentation, Dr. Tatum will cover some of the philosophies and principles used to guide ASD product formulation.

Learning Objectives:

ASD Intermediate Development – Formulation Design & Technology Selection
Considerations for spray drying vs. HME in early development

Continue to Part 2 for:

ASD Product (Tablet) Design
- Considering TPP / Product Design in ASD screening
- Considering impact of particle properties (SDD vs HME) in product design & performance

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Wesley Tatum, PhD

Principal Engineer, Process and Product Development

Wesley Tatum is a Principal Engineer in the Process and Product Development department at Serán. He leads a team of scientists and engineers in characterizing new API and identifying shortcomings for bioavailability. He and his team then screen and select drug product intermediates that address those shortcomings and screen and scale up drug product formulations. During his time at Serán, his work and research has focused on understanding how polymers, excipients, and physiological factors influence speciation, bioavailability, and absorption of drug substances and amorphous solid dispersions.

Wesley holds undergraduate degrees in Physics and Physical Chemistry from Whitworth University and a Ph.D. in Materials Science and Engineering from the University of Washington.

About Serán

Serán's Science-First Approach

Serán Bioscience is a science-based CDMO that specializes in a variety of drug delivery and formulation approaches suited to optimizing bioavailability. Our experienced formulation team will work with you to identify an appropriate technology and formulation strategy to meet your program’s unique needs. We take a comprehensive approach to formulation design that considers the physiochemical properties of the API, the target product profile, and your program’s objectives and constraints to develop scalable formulations using efficient and material-sparing approaches.

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