Scale-Up

What is scale up?

Scale up in manufacturing refers to increasing the batch size of a drug product. If a pharmaceutical drug is successful, it has the potential to scale up multiple times in order to meet growing demand. However, once demand for the drug begins to decline, scaling down will occur.

When new drug formulations are in the research and development phase, the opportunity to manufacture the drug at a commercial scale should be considered. Factors like safety, efficacy, and economic factors must be considered in the scale up process.

Learning Objectives

• Describe the different scales and what part of the drug development process they are used in
• Define critical quality attributes and describe how they are identified
• Discuss different challenges companies might face in the scale up process