This episode provides an overview of the essential purification and isolation techniques used in pharmaceutical manufacturing to obtain drug substances of the required purity. We'll explore three core methods: crystallization, filtration, and chromatography. The discussion will explain the fundamental principles behind each technique and how they're applied to separate the desired drug molecule from unwanted impurities or byproducts.

The conversation will also delve into the challenges of scaling up these purification methods to industrial production levels. We will illustrate how scientists optimize these techniques to achieve both high purity and high yield, while adhering to strict regulatory standards. Real-world examples from OPR&D will showcase how these techniques are used in practice. Topics covered will include: crystallization, chromatography, filtration, solubility, and polymorphs.