From protein to patients
Chemistry, Manufacturing and Control (CMC) Supply develops, produces and formulates all new protein and peptide processes for Novo Nordisk. In addition, we create the labelling for finished drug products to be used in clinical trials and ship them to these sites all over the world.
CMC Supply's main deliverables are:
- The manufacture and distribution of drug product to non-clinical and clinical testing sites
- Development of commercial manufacturing processes and technologies
- Generation of approvable scientific documentation and applications for regulatory and health authorities.
CMC Supply makes up a workforce of just over 1,200 employees representing a range of competency areas from industrial operators to protein chemistry specialists. Everyone has an important function in CMC, from developing customised processes to manufacturing and formulating new proteins. One main project that we are working on is the formulation of oral or tablet forms of both insulin and GLP-1, with several candidates currently in clinical development.
The challenges of developing insulin in a tablet
Our expertise: Proficiency in protein processing, up-scaling and formulation
CMC Supply masters recombinant protein expression in bacteria, yeast and mammalian cells in multi-tonnes scale, purification and synthesis. From cell bank to final drug product, we provide state-of-the-art process development, up-scaling and formulation with the proper safety and convenience profile and the right product efficacy.
During the preclinical and exploratory clinical development phases, our work leads us to decisions on the preliminary and final manufacturing methods of both the active pharmaceutical ingredient and the therapeutic product, specifications and analytical control methods.