The art of scale up : where development meets manufacturing

By Mina Samir Categories: Production
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About Course

This course is designed to bridge the gap between laboratory formulation and commercial manufacturing, covering the main principles required for successful technology transfer. Participants will first master the basic concepts and similarity criteria governing scale-up before exploring practical, dosage-specific applications across solid, liquid, and semi-solid systems. The modules then deep-dives into Quality by Design (QbD) frameworks to clearly differentiate between Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), establishing robust design spaces. Finally, the course addresses troubleshooting, failure mode analysis, and lifecycle process validation to ensure consistent product quality, regulatory compliance, and process robustness at scale

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What Will You Learn?

  • By the end of this course the student should be able to:
  • Understand the definition of a scale-up process.
  • Identify the core objectives of pharmaceutical scale-up.
  • Learn about ICH Q 8, 9, and 10.
  • Explore practical examples and tips about the scale-up process.
  • Recognize the desi.gn space concept.
  • Identify critical process parameters and their effect on critical quality attributes on different manufacturing steps.
  • Explore various examples of troubleshooting during the scale-up process.
  • Identify the stages of process validation.
  • Understand the steps of risk assessment process

Course Content

Module 1: Basic concepts.

  • MODULE 1 SCALE UP.mp4
    37:47
  • Module 1 Quiz

Module 2: Practical examples

Module 3: Critical process parameters vs. critical quality attributes.

Module 4: Trouble shooting , risk analysis and process validation.

Final quiz

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