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As spray-dried dispersions (SDDs) become more common in enabled drug product development, early identification of process and product risks is critical to reduce timelines and material costs. A proactive approach helps build process knowledge from early clinical manufacturing through PPQ, allowing more time for optimization ahead of commercialization.

This webinar will outline the process qualification lifecycle for SDDs and share how Serán Bioscience applies a “Right from the Start” approach to support development. Learn how early-stage strategies can minimize API use, reduce risk, and streamline development to improve patient outcomes.

Key Takeaways:

• Overview of the SDD process qualification workflow

• Key scale-up parameters and how lab-scale data informs commercial-scale design

• How to apply a risk-based framework to guide development strategy for drug product intermediates

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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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