2.1 What is CMC or Technical R&D?

Any new drug (molecule or other modality) needs to be transformed into a product that can be used in clinical studies and, ultimately, as a commercial product.

Technical R&D or CMC (Chemistry, Manufacturing, and Control) comprises all functions and activities involved in the development of new molecules (NCEs, NBEs, or other modalities) related to the manufacture, analytical testing, and packaging of the product. The different modalities include:

• Small molecules

• Synthetic peptides

• Biologics (mABs, antibody fragments, and other proteins)

• Antibody- drug-conjugates (ADC)

• Gene therapy, cell therapy, and other ATMPs

CMC / Technical R&D activities consist of:

• Drug substance: definition of the drug substance (incl. salt selection, polymorph, etc.)

• Drug product: Selection/definition of the appropriate drug product (= dosage form = formulation) based on the route of administration and the molecule properties

• Manufacturing processes: development of suitable processes for both drug substance and drug product

• Analytical methods: Development of analytical methods to characterize both drug substance and drug product

• Packaging: Selection of container/closure system (primary packaging configuration, i.e., material in direct contact with the drug product)