CMC Supply
In CMC Supply (Chemistry, Manufacturing and Control Supply) we develop, produce and formulate all new protein and peptide processes for Novo Nordisk as well as perform labelling and shipment of the finished drug products to clinical trials worldwide.
The customers primarily consist of other R&D units and the Product Supply division, and our end-products can be grouped into three core deliverables:
- Manufacturing and distribution of drug product to preclinical and clinical testing sites
- Development of commercial manufacturing processes and technologies
- Generation of approvable scientific documentation and applications for regulatory and health authorities
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.
We also support the approval process by providing the relevant regulatory and health authorities worldwide with documentation for the safety and quality of our processes and products.
