The Diabetes Epidemic

Diabetes is not only serious. It is also extremely expensive. The cost of treating diabetes worldwide in 2019 was an astonishing $760 billion according to the IDF — or 11% of total global healthcare spending — and is expected to reach $845 billion by 2045.

Diabetes is a group of incurable diseases in which the sufferer has high levels of blood sugar. This is caused by the inefficient production of the hormone insulin in the pancreas.

There are two main types of human diabetes. In type 1, the body either does not produce insulin at all, or produces it in wholly inadequate quantities. This type is often inherited and/or genetic. In type 2, insufficient insulin is produced, or the body’s cells fail to use it properly. Type 2 diabetes is largely the result of lifestyle factors — and it accounts for 90% of all cases.

Undiagnosed

Diabetes has traditionally been viewed as a disease of affluence. In most rich countries, it is the fourth or fifth leading cause of death. However, 80% of diabetics actually live in countries that are classified by the World Bank as low- or middle-income: and, worryingly, an estimated 183 million people — or 50% of the global total — are unaware of the fact that they even have the disease. In Africa, 80% of diabetics are undiagnosed.

It is from these poorer countries that the bulk of the epidemic increase will come as people live longer and, as a result of rapidly increasing urbanization, eat higher calorie diets while doing less physical activity. Yet the health systems in many of these impacted countries are not currently equipped to meet the rising demand. 

Perhaps unsurprisingly, it is the world’s biggest countries that have the most diabetics. Today’s top three — China, India and the USA — are also forecast to be the top three in 2030. But the prevalence of diabetes — the proportion of a population that has the disease — paints a very different picture. Four of the top ten are Pacific island states: the other six are all in the Middle East and the only change during the next 20 years is predicted to be the order in which they appear. Around 20% of people in the Middle East are diabetic.

Life Saving

Injections of insulin are the main form of treatment for type 1 diabetes, for which they are life-saving. They are also often required in the later stages of type 2 of the illness. Insulin was discovered in 1921, as a result of Nobel Prize-winning work by a group of Canadian scientists, and was first used to treat diabetes on 11 January 1922. Yet, until the 1970s, clinical insulin was mainly derived from the pancreases of cows and pigs as insulin from these sources is almost identical to that of humans. 

However, in 1982, the first biosynthetic “human” insulin was produced using genetic engineering techniques and recombinant DNA (r-DNA) technology. In simple terms, this involves actual human DNA being inserted into host cells, often using E. coli bacteria or bakers’ yeast cells. The hosts are then allowed to grow and reproduce normally and, owing to the inserted human DNA, produce a synthetic version of human insulin.

This is the process being used at the Julphar (Gulf Pharmaceutical Industries) manufacturing plant in the United Arab Emirate of Ras Al Khaimah. Representing an investment of more than $135 million, this 20,000 square meter plant is one of the largest insulin production facilities in the world and will manufacture 1500 kg of product a year.

GEA, which supplies specialist process systems for the pharmaceutical and biotechnology industries, was approached by Julphar to work on the project and, during the next 5 years, the company was responsible for the planning, engineering, delivery and commissioning of the entire sterile pharmaceutical production system. The plant has 5000 square meters of cleanrooms and more than 17 km of clean pipework. 

The GEA package also included managing the process integration of all the main manufacturing elements, such as fermentation, harvesting, chromatography, filtration and freeze drying. 

Furthermore, GEA’s centrifugal technology plays a central role in the production process. Manufacturing biosynthetic human insulin involves fermenting cells and then separating them in a high-speed centrifuge. The five separators installed at Ras Al Khaimah are used to recover the E. coli bacteria from the fermentation broth, purify the output and concentrate the insulin crystals following their precipitation.

The cells then need to be ruptured. GEA’s very high-pressure homogenizers offer a quick and effective method of disrupting the cells that can be reproduced on an industrial scale. The pressure can be varied to achieve the right degree of cell rupture and the equipment can be sterilized without being disassembled.