With the commissioning of two new 500 litre GMP manufacturing suites, Rentschler Biotechnologie says it looks forward to completing the first phase expansion of its operations
The new fermenter lines with 500 litre working volume each are sized such that, depending on the respective requirements, different cell culture processes can be run (batch, fed-batch, or perfusion).
Both systems will be used to produce therapeutic proteins and monoclonal antibodies.
The ensuing 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 2500 litre multi-process fermentation suites is slated for commissioning in mid-2008.
Both can optionally be used to run perfusion processes.
The 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.
Demand for corresponding manufacturing capacity is rising in parallel.
Besides allowing Rentschler to offer its customers development and manufacture of biopharmaceutical drugs for the phases of clinical trials, the company's expansion project launched in 2006 (Rex = Rentschler expands) will also pave the way to future market supply of large output volumes of active pharmaceutical ingredients.
As a full-service contract manufacturing organisation (CMO), Rentschler Biotechnologie now offers a total of eight stand-alone GMP suites (ten suites from mid-2008 on) to the market for process development on the smallest scale up to cGMP production in the 2500 litre range.
Besides process development and production including formulation and fill and finish, add-on services such as assistance in drug registration and formulation development are being offered.
This eliminates the need for costly and time-consuming technology transfer.
