Optimizing SDD Development: Risk-Based Strategies for Spray Dried Dispersion Process Qualification Success

Webinar Date: On-Demand
Time: 11:00 AM Pacific Daylight Time
Duration: 1 hour
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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. 

What you will learn:

  • 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

Who should attend:

  • Formulation Scientists
  • CMC Leaders
  • CMC Consultants
  • Product Development and Program Managers
Principal Engineer
Serán BioScience
Image Mike Auerbach
Editor-in-Chief
American Pharmaceutical Review

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