Production of Insulin
Being overweight and a lack of exercise mean that diabetes is becoming a global illness. Diabetes means that the human body does not produce sufficient insulin and/or is unresponsive or resistant to insulin. In its advanced stage, insulin is therefore administered in the correct dose to the patient as a life-saving measure.
In general, the remaining life expectancy of patients is reduced by approximately one third after the point at which the illness is diagnosed. It is estimated that, globally, 415 million people are living with diabetes, which is approximately 9.1% (or one in every eleven people) of the world’s adult population. Yet, 46% of people with diabetes are undiagnosed. This figure is expected to rise to 642 million people living with diabetes worldwide by 2040.
New Middle East Production Facility for Julphar
To address the growing need for insulin, Julphar (Gulf Pharmaceutical Industries) in the United Arab Emirates commissioned a new insulin factory. Similar to many other production facilities throughout the world, this facility was to be equipped with mechanical separating technology from GEA. As the largest producer of antibiotics delivered in oral or injectable form in the Middle East, Julphar produces its own brands and also operates as a subcontractor to meet worldwide demand under GMP conditions. Its factories are also ISO-certified.
Julphar pioneered the production of insulin in the Middle East and Africa. The company has been distributing insulin in co-operation with a French manufacturer since 1998; at that time, Julphar imported the insulin crystals. Taking a proactive step in this expanding market, Julphar decided to manufacture the raw material for insulin itself. This was a logical decision because, according to the International Diabetes Federation (IDF), there are already an estimated 32.6 million diabetes sufferers in the region, and this figure is expected to double by the year 2030. The diabetes rates in the Middle East and North Africa are some of the highest in the world.
Core Processes from GEA
Julphar’s production facility in Ras Al Khaimah, north of Dubai, is one of the most modern in the world for manufacturing insulin crystals for human consumption. It covers a floor area of 20,000 m2, including 5000 m2 of cleanroom space. Fifteen kilometers of pipework have been installed. GEA was responsible for the engineering, delivery, commissioning and qualification of the entire plant — from the production of ultra-pure media to all the various process equipment and cleaning installations. In addition, the delivery comprised all the necessary pipework and distribution systems for the production processes.
As a production technology, Julphar uses a recombinant DNA (r-DNA) technique and inserts the insulin gene into a suitable production organism, in this case Escherichia coli. The genetic constitution of the bacterium is modified in such a way that it produces the human hormone insulin.
In various stages, the bacteria then multiply in fermenters and are subsequently recovered and purified in separators. Separators thus constitute one of the core processes in the production of insulin. Because GEA is known as a trusted supplier of plant for the production of insulin, Julphar was keen to capitalize on the company’s know-how and centrifugal technology expertise. GEA installed a total of five separators in Ras Al Khaimah.
A CFA 65 nozzle-type separator with GEA viscon® technology is used to separate the E. coli bacteria from the fermentation broth; in this solution, the solids are continuously discharged with a constant concentration. Following the homogenization stage, two self-cleaning CSE 80 separators isolate the inclusion bodies from the cell fractions and wash them. Following the precipitation of the insulin crystals in the cleanroom, two BKA 28 chamber-type separators are then used to segregate the crystals and thus produce concentrated insulin.
Hycon as an Alternative
As an alternative to the production of insulin from Escherichia coli, other producers use yeast as the production system. The process is similar, but the valuable substance in this case is not the solids; it’s actually the clarified phase. In both methods, GEA Hycon machines can be used as a substitute to the chamber-type separator after the crystallization process. Hycon is a completely closed system that enables the separating process to be done under cleanroom conditions with no risk of contamination by the drive or motor.
Utilizing the suspended bowl principle, this twin-room concept has the bowl with the hood and solids holding tank in the cleanroom, whereas the drive units can be housed in a separate room with a lower classification. The machine is designed in such a way that the solids are automatically discharged from the suspended separator into closed containers installed below the separator.
Here, GEA technology achieves very gentle product treatment — which is essential for the high value material — by means of two features: the hermetic feed and the controlled discharge. Whereas chamber-type separators are not sterilized normally and can only be cleaned manually, Hycon machines benefit from fully automatic cleaning and, when necessary, sterilization by means of CIP and SIP.
The Silent Killer
