Laupheim, July 23, 2007
With the commissioning of two new GMP manufacturing suites, Rentschler Biotechnologie looks forward to completing the first phase expansion of its operations. Both systems will be used to produce therapeutic proteins and monoclonal antibodies.
The new fermenter lines with 500 L working volume each are sized such that, depending on the respective requirements, different cell culture processes can be run (batch, fed-batch, or perfusion). 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 2,500 L 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 organization (CMO), Rentschler Biotechnologie now offers a total of eight stand-alone GMP suites (10 suites from mid-2008 on) to the market for process development on the smallest scale up to cGMP production in the 2,500 L range. Besides process development and production including formulation and fill & 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.
About Rentschler Biotechnologie - www.rentschler.de
Rentschler Biotechnologie GmbH is part of the Rentschler Group based in Laupheim, Germany. As an international full-service contract manufacturer with a highly skilled staff of 310, Rentschler Biotechnologie has more than 30 years of experience in the development, production and approval of biopharmaceuticals in compliance with international GxP standards. Regulatory advice and fill & finish are part of the company's service range. As a pioneer in the development and production of biopharmaceuticals, Rentschler was the first company in the world to gain market authorization for an interferon-containing drug. In 2006, Rentschler announced an investment program of € 50 million for expansion of production systems. The first new 500 L system went into operation in mid-2007.
For more information about Rentschler Biotechnologie, please contact:
Dr. Wieland Wolf
Dr. Rentschler Holding GmbH & Co. KG
Phone: +49 (0)7392-701-0
Rentschler Biotechnologie GmbH
Phone: +49 (0)7392 701-555