PRONOVA. One of the companies producing a drug that fights the consequences of obesity is the Norwegian company Pronova BioPharma. Their marine-oriented omega-3 product treats elevated levels of triglycerides, which is one of the conditions categorised as dyslipidemia. The product is the first of its type to be approved as a prescription drug by the EU and FDA.
Transforming the product from a dietary supplement into a prescription drug required specialists, because Good Manufacturing Practice (GMP) for medicine is significantly stricter than for dietary supplements. At the same time Pronova experienced an increase in market demand, which led to the need for a new production plant.
Pronova has worked with NNE Pharmaplan when the existing plant in Sandefjord, Norway was expanded and upgraded and when the new facility in Denmark was established in 2009.
DEUTSCHES HERZZENTRUM. At the Deutsches Herzzentrum in Berlin human replacements for heart surgery is produced from hearts not suitable for direct transplantation. The tissue from the hearts is prepared in sterile conditions, frozen and kept in liquid nitrogen until they are needed for an operation. In order to produce and market the tissue all parts of the process must be under strict control and meet Good Manufacturing Practice. Between 2006 and 2008 Deutsches Herzzentrum upgraded their facilities to meet all GMP requirements including cleanrooms with continuous particle monitoring and a suitable air-lock system. By the end of 2008 they were given manufacturing authorization by local inspectors. NNE Pharmaplan helped Deutsches Herzzentrum qualify the facilities and document that they meet Good Manufacturing Practice. NNE Phamaplan provides ongoing consulting services to the company, e.g. on technical documentation needed to meet European Union legislation.
DEEP BRAIN STIMULATION. A promising, yet controversial treatment against obesity is called deep brain stimulation. Deep brain stimulation is a surgical treatment involving the implantation of a medical device called a brain pacemaker, which sends electrical impulses to specific parts of the brain. It works by putting two electrodes into the brain and using them to control the activity in the part of the brain that regulates hunger. Deep brain stimulation is already used against depression, Obsessive Compulsive Disorder (OCD) and other diseases in some countries. Now treating obesity by lowering appetite can be added to the list. The US based global company Medtronic INC is one of the pioneers in a business that needs forerunners in the fight against overweight.
Read more on the theme obesity in our company magazine Angle, June 2010 issue