PROTINUS is the name of the project with which the biopharmaceutical company CSL Behring will significantly increase the production capacity of immunoglobulin at its site. GEA received the order for the process plant, the heart of the facility.
The two additional production lines will enable a further 90,000 patients per year to be supplied with life-saving drugs. Thanks to the good cooperation of all parties involved in the project, it was possible to continue the project on schedule despite the global corona pandemic.
Following the successful commissioning of the modules I and II also in Berne, Switzerland (2007 and 2009) and modules III and IV at CSL Behring's Melbourne, Australia site (2013 and 2017), this is now the third GEA process plant at CSL Behring to be commissioned with modules V and VI.
Plant and process safety
CSL Behring relied on GEA not only because of the good experience with the previous projects in Berne and Melbourne. As a supplier of sterile process plants with many years of experience, GEA can draw on the extensive theoretical knowledge and professional competence of its engineers to provide modern, customised and cost-efficient process lines for the production of new drugs in accordance with the current requirements of the global drug regulatory authorities.
The technological competence for the biotechnology industry includes cultivation, fermentation, separation, homogenisation, crystallisation, concentration, freeze drying and fractionation, complemented by a comprehensive range of bioreactors, fermenters, vessels and high-quality components. GEA plants are also characterised by high availability and economical operation.
This is backed up by a long history, combined with a great deal of competence and experience in this field. In fact, the first pharmaceutical built back in the 1970s. Since the 1980s the company has strategically focused on biopharmaceutical applications.
Integration in the engineering process
The PROTINUS project in Berne had other success factors. For example, GEA was able to build on the many years of experience gained with the running plants in Berne and Melbourne. This was another reason why GEA was involved in the engineering process from the very beginning. Together with CSL Behring, GEA continued to work on the degree of automation and took it to new levels.
Significant progress was made in the areas of "increased availability", "operability" and "safety". A concrete example: As an improvement on the previous modules, a purely manual switchover panel could be replaced by a complex valve combination in the cleanroom.
This allows CIP cleaning and product transfer without risk of contamination in parallel and without manual operator actions.
Immunoglobulin
"Our greatest incentive in this project is that the additional production capacity will enable around 90,000 people per year to lead a normal life," said Pierre Caloz, Head of Manufacturing EU & APAC, CSL Behring. CSL Behring has therefore invested 250 million Swiss francs in the project, creating 50 new jobs.
Immunoglobulins are proteins of the globulin class. They are used to defend the human organism against foreign substances that have entered the body. They therefore play a central role in the immune defence. They are used in autoimmune diseases as well as in passive immunisation against certain pathogens and in cancer therapy.
