Overview of Risk-Based Development Strategies and Process Qualification for Spray Dried Dispersions

Recent trends in the development of enabled drug products containing spray-dried dispersions (SDDs) demonstrate the need for early determination of process and product risk throughout the development lifecycle to reduce development time and material cost. These risks can help inform development strategies to bolster process knowledge from early clinical manufactures up through process performance qualification (PPQ), bolstering the overall time available for process optimization prior to commercialization.

This discussion will highlight the overall process qualification lifecycle for SDDs and the strategies that Seràn Bioscience typically uses to support SDD intermediates throughout this process using a “Right from the Start” philosophy. These strategies are aimed at informing process decisions early in the development lifecycle while minimizing development API requirements to minimize process risk, accelerate timelines, and overall improve patient outcomes.

Takeaways/Objectives

Overview of the process qualification workflow as related to spray-dried intermediates
Understand the typical scaling parameters that define the spray drying process design space and how these variables can be informed at the small scale and translate to production scale
Understand how to apply a risk-based framework to identify an appropriate development strategy for different drug product intermediates and other problem statements

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Tony Vickery

Principal Engineer

Process & Product Development

Tony Vickery is a Principal Engineer in the Process and Product Development group at Seràn Bioscience. He leads a team of engineers responsible for developing processes related to particle engineering and enabled drug product intermediates (i.e. spray drying, hot melt extrusion, particle size reduction, etc.). His team is also responsible for the scale-up development efforts required to take a process fit for early clinical manufacturing to the late phase clinical and commercial production scale. During his time at Seràn, Tony has been responsible for scaling various SDD intermediates to the production scale, designing and managing Seràn’s development manufacturing lab, and implementing safety and workflow procedures to improve operational functionality.

Tony has worked in the CDMO space for nine years, primarily focused on early and late phase process development related to enabled drug product intermediates, including spray-dried dispersions and inhalation products. He holds a B.S. in Bioengineering from Oregon State University.

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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