This session delves into a risk-based approach for supporting process qualification of amorphous solid dispersions produced by spray drying. Our expert speakers discuss the integration of process design and qualification into the broader process validation strategy, emphasizing how small-scale experiments can optimize drug substance usage and mitigate risks during the qualification stage.

We also cover critical elements of product design, illustrating how a risk-based approach can create robust processes with inherent manufacturing flexibility. Through compelling case studies, we demonstrate the application of in-process hold times at full scale. Don’t miss this opportunity to gain valuable insights and practical strategies for your process qualification needs.

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Key learning objectives:

  • Gain insight into the commercial capabilities of Lonza Small Molecules.
  • Discover the essential attributes of SDD formulations and their production process.
  • Learn how small-scale experiments can guide process qualification to minimize risk and conserve materials.
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