Rentschler Biotechnologie commissions new 500-litre GMP manufacturing suites
With the commissioning of two new GMP manufacturing suites, contract manufacturing organisation Rentschler Biotechnologie is completing the first phase of the expansion of its operations. Both will be used to produce therapeutic proteins and monoclonal antibodies.
With the commissioning of two new GMP manufacturing suites, contract manufacturing organisation Rentschler Biotechnologie is completing the first phase of the expansion of its operations. Both will be used to produce therapeutic proteins and monoclonal antibodies.
The new fermenter lines with a working volume of 500 litres each are sized to allow the running of different cell culture processes, including batch, fed-batch, or perfusion, depending on requirements. The subsequent protein purification is performed with state-of-the-art processes in two suites upstream and two suites downstream of the obligatory virus inactivation.
The first of two new 2,500-litre multi-process fermentation suites is scheduled for commissioning in mid-2008. Both can optionally be used to run perfusion processes. The e50m expansion project as a whole comprises a new laboratory building, a central energy station, a logistics space as well as additional facilities for sterile filling of syringes and injection vials.
The global market for therapeutic proteins and monoclonal antibodies is growing continually, and demand for corresponding manufacturing capacity is rising in parallel. Besides allowing Rentschler to offer its customers development and manufacture of biopharmaceutical drugs for clinical trials, the company's expansion project, launched in 2006, will also pave the way for future market supply of large output volumes of APIs.