GEA was responsible for the installation of a new immunoglobulin (IgG) manufacturing plant, including detail design engineering, for an annual capacity of more than 3 million litres of PEQ (plasma equivalent).
Wide Range of Filtration Technologies
The whole procedure starts by resuspending the precipitate to produce the final formulated bulk, including the integration of several different treatment and virus inactivation steps — depth filtration to remove protein contaminants, anion exchange chromatography to deplete residual impurities, dia/ultrafiltration to remove process residuals and to concentrate the protein and/or nanofiltration to remove very small particles — all fed using 32 high quality GEA pharmaceutical product and buffer tanks (1000–8000 L).
Through continuous improvements of the P&IDs (Process & Instrumentation Diagrams) during the detail engineering phase, the latest technological advances have been integrated into the immunoglobulin production process. As well as various maintenance and ease of operation aspects, special attention has been paid to the capacity of individual plant areas, allowing future potential development in terms of output and yield, should reconstruction be necessary. The highly automated process ensures lot-to-lot consistency and product quality.
Full automation of the plant, including the cleaning processes (SIP, sanitization in place), ensures that the plant can operate almost autonomously, which is a significant advantage. The result is an efficient manufacturing process and plant that’s based on the highest technological, viral safety and purity standards, which will give the patients the confidence and peace of mind that they are receiving high quality immunoglobulin products.