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Reflection on CMC in the Biotech world

CMC, short for "Chemistry, Manufacturing, Controls", puts Chemistry in the spotlight, but it is our mastering of Biology that brought us our latest and most exciting achievements, such as the mRNA vaccines. With the focus shifted from chemical reactions to biological pathways, we are now able to make products that interact with our physiology in increasingly intricate ways.

Manufacturing biological products is vastly more complex than small-molecules. We rely on living organisms to make these products and as we all know, living organisms tend to have their own agenda. In the field of biologicals, the common saying is: "The process is the product" as one can’t fully characterize a product without understanding the fingerprint left by the process.

Controls have evolved over the years to answer this complexity, culminating in the concept of Quality by Design. We no longer rely on analytical controls to ensure quality- we develop our processes such that they would consistently deliver quality products no matter their complexity, through the insights gained with science- and risk-based approaches.

So, in my view, CMC of Biological products is better described as: BMD- Biology, Manufacturing, Design, which is a step Beyond CMC.


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