Industrial scale production of Recombinant Insulin (Humulin) to combat Type-1 Diabetes Mellitus (IDDM)

Abstract

Type 1 diabetes is a common disease which affects people right from their childhood. The main cause of type-1 diabetes is the deficiency of insulin which is produced by ‘beta’ cells in the body. With destruction of ‘beta’ cells, the production of insulin which regulates the blood sugar levels in the body from the pancreas is halted which results in imbalance of blood sugar levels in the body.

In the past, diabetes, both types 1 and 2 were treated using bovine and porcine insulins or a mixture of them by extracting them directly from their respective sources and purifying them [1]. In recent times, with the rise in recombinant technology and the rise in biopharmaceutical engineering, recombinant insulin has seen a rise in market due to rise in ethical issues concerning using insulin or biopharmaceuticals produced from other life forms, mainly animals.

This design report focuses on the production of recombinant insulin using E. Coli as the host and meeting the demand of a growing and emerging market in the world. The unit operations along with the material balances to describe the scale are described in detail to justify the requirements of the demand with a focussed purity of greater than 99%. Several possible suggestions and expansions are also described later in the report which can come to aid in the growing market with a possibility of using microbubble intensified bioprocessing in the process line and good manufacturing practices (GMP).