“Protinus” (lat. forward, further”) 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.
According to Gea, the two additional production lines will enable a further 90,000 patients per year to be supplied with life-saving drugs. Due 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, Gea mentioned in a press release. 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.
High demands on plants 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, customized and cost-efficient process lines for new drugs following the current requirements of the global drug regulatory authorities. The biotechnology industry’s technological competence includes cultivation, fermentation, separation, homogenization, crystallization, concentration, freeze-drying, and fractionation, complemented by a comprehensive range of bioreactors fermenters, vessels, and high-quality components. Gea plants are also characterized 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. The first pharmaceutical plant was built back in the 1970s. Since the 1980s, the company has strategically focused on biopharmaceutical applications.
Integration in the engineering process and continuous improvements
The “Protinus” project in Berne had other success factors. For example, Gea built 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 ‘increased availability,’ ‘operability’ and ‘safety’. 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 manual operator actions.
“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,” says Pierre Caloz, head of Manufacturing EU & APAC, CSL Behring. CSL Behring has therefore invested Swiss francs 250 million (approximately Rs 2000 crore) 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 defense. They are used in autoimmune diseases and passive immunization against specific pathogens and cancer therapy.