Strategies for Amorphous Solid Dispersion Product Development

In this talk, presented during the 2024 Global Drug Bioavailability Enhancement & Controlled & Modified Drug Release Summit, we present a multifaceted approach to technology selection for enabled formulations. We demonstrate how to leverage a combination of measured and calculated molecular properties, bio-performance modeling, and a strategic understanding of the product TPP to identify a technology to enable exposure and an appropriate drug product design.

For successful development of a rapidly advanceable and patient-friendly enabled drug product, the development of the drug product intermediate cannot be decoupled from the drug product design. We introduce a case study that highlights these principles and strategies in addition to providing a comprehensive overview of ASD formulation and drug product design principles.

KEY TAKEAWAYS:

Strategic drug product design supports a flexible TPP that allows for development of a relevant and advanceable dosage form for FIH studies
Considering TPP/Product Design in ASD screening
Considering impact of particle properties (SDD vs HME) in product design & performance

Watch The Presentation

Erica Schlesinger, PhD

Vice President of Technical Development, Process and Product Development

Erica Schlesinger is Serán’s Vice President of Technical Development. She leads a team that applies scientific rationale and engineering design to problem-solving and pharmaceutical product development. Her research interests include spray-dried biologics (mAb, Phage, Virus, Whole Cells) and controlled-release technologies for long-acting therapeutics.

Erica has over 15 years of experience in pharmaceutical formulation development, process chemistry, and the early-stage development of novel drug delivery systems, and prior to joining Serán, she worked at Genentech, Seattle Genetics, and Regeneron.

Erica holds an undergraduate degree in Chemical Engineering from Cornell University and a Ph.D. in Bioengineering from the Joint Graduate Group in Bioengineering at the University of California San Francisco and UC Berkeley.

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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