Insulin therapy is the mainstay of diabetic patient management. 700 million adults will have diabetes by 2045 (Source: International Diabetes Federation). In order to meet this rising demand, especially in BRICS countries, traditional manufacturers and market newcomers are still looking to improve drug design and production.
Whilst well known and established, the insulin production process remains complex. Several steps are required from fermentation to formulation and each one can generate heterogeneities and influence the quality of the final product.
The choice of expression system (DNA construct) and host organism (Escherichia coli, Saccharomyces cerevisiae and Pichia pastoris yeasts) is critical and will influence the production process. Various strategies can also be applied for the purification and isolation steps, involving both chemical or enzymatic modifications within the global downstream process.
Novasep is a recognized expert in insulin purification. We have developed processes and installed equipment for the largest players in the market. From the development stage right up to industrial scaling, we provide a complementary range of GMP equipment and services for purification.
Insulin production processes are now mature, but our teams continue to work tirelessly to improve production performance.