Rentschler Biotechnologie, New Manufacturing Capacity, Laupheim, Germany

Rentschler Biotechnologie GmbH is a full-service contract manufacturer and part of the Rentschler Group based in Laupheim, Germany. The company has been involved in the industry for over 30 years and provides a full range of services for development, production and approval of biopharmaceuticals in compliance with CGMP (3,500m², 37,660ft² of floor space).

The company is now primarily engaged in development, clinical testing, production, fill and finish and analysis of proteins for human therapeutic or diagnostic use according to international standards.

The company employs 350 personnel and was the first in the world to obtain authorisation for an interferon type drug.

The company is now responding to demand for manufacturing capacity in the biotech sector by carrying out a major expansion project. It invested €70m in the facility for the period up to 2002.

Dr Nikolaus F Rentschler, CEO at Rentschler Biotechnologie, commented: "By expanding our production capacity we will establish Rentschler Biotechnologie as a market supplier of antibodies". Rentschler's main customers are Maxygen (novel factor VIIa protein) and Roche.

CONTRACTORS

NNE Pharmaplan is the company responsible for the orchestration of all the qualification processes required during the expansion project, which was set to run from September 2005 to September 2008.

Services provided include validation of the master plan, preparation of qualification SOPs, risk analysis, design qualification, coordination of complete installation and operational qualification and part execution of installation and operational qualification.

PHASE ONE EXPANSION

Rentschler has experienced a period of expansion that began in 2006 with two 500l fermenter systems, requiring an investment of €50m and going into operation on 24 July 2007. Both of these new systems will be used to produce therapeutic proteins and monoclonal antibodies.

The new lines are sized so that, depending on the respective requirements, different cell culture processes can be run (batch, fed-batch or perfusion). The resulting protein purification can then be performed with state-of-the-art processes in two upstream suites and two downstream suites following the virus inactivation process.

PHASE TWO EXPANSION

The first of two new 2,500l multi-process fermentation suites will be commissioned in mid-2008. This is a €50m investment that will include 100 new jobs. Both of these suites can optionally be used to run perfusion processes.

The total expansion project includes a new laboratory building, a central energy station and logistics space, as well as new facilities for sterile filling of syringes and injection vials.

This will negate the need for technology transfer as all processes can be carried out at one facility.

The phase two expansion will give Rentschler a total of 10 GMP suites for production of biotech compounds. The compounds will have volumes of from 2,500l to 30l, for commercial to clinical trial quantities. Rentschler also has a 'preferred partnership' agreement with Boehringer Ingelheim so that customers requiring higher production capacities can receive easy access to Boehringer's large-scale bioreactor volumes of up to 15,000l.