CMC Supply
Proficiency in proteins and up-scaling
CMC Supply (Chemistry, Manufacturing and Controls) develops and produces all new proteins and peptides for clinical trials worldwide. From cell bank to final product, we provide state-of-the-art process development, up-scaling and preparations in the right quantities and qualities at the right time and with the proper safety profile.
Novo Nordisk masters multi g/L recombinant protein expression in bacteria, yeast and mammalian cells in up to 160,000 L scale.
Our process development
In the late research phase and during the preclinical development phase, we focus on the molecule – its physical/chemical properties including pre-formulation, how it should be produced, what kind of impurities and degradation products we can expect, and so on.
During the exploratory clinical development phase, our work helps lead us to decisions on the final manufacturing methods of both the active pharmaceutical ingredient and the therapeutic product, specifications, analytical control methods, and choice of delivery system.
In parallel, we develop, document, produce, and label products for use in clinical trials worldwide.
By the time we transfer activities to Production and Control Laboratories, who will market the new products, we document the entire CMC development process for use in the regulatory file inspection by authorities.
See our other units in R&D
Diabetes Research Unit
Biopharmaceutical Research Unit
Device R&D
Global Development
Regulatory Affairs
