1.2- Drug manufacturing and CMC
Welcome to Session 2 of The Drug Development Journey.
Today. we will go through the pillars of CMC- Chemistry, Manufacturing and Controls, and see how they are interconnected.
We will discuss how the field has evolved from the early days of "Chemistry" to today's complex Biological products, and how "Controls" are no longer sufficient as we speak the language of Quality by Design.
In the world of Biologicals, CMC is better described as BMD- Biology, Manufacturing, and Design, which is a step Beyond CMC :)