Laupheim, Germany, June 20, 2014 / B3C newswire / – Rentschler Biotechnologie GmbH, a leading contract manufacturing organization (CMO) for the development and production of biopharmaceuticals, announces the investment of €24m to build a Twin system with two 3,000 L stainless steel bioreactors mainly targeting market supply at the company’s site in Laupheim, Germany. The Twin system should be operational in early 2017.
The Twin system is designed for running two main bioreactors in parallel with one shared downstream processing unit thus providing higher throughput while reducing incremental labor costs involved. It integrates well into the existing 3,000 L GMP line and will more than double the production capacities for cell culture-derived proteins. The Twin system allows us to run cell culture processes in fed-batch mode with a very high output in a single suite.
“The expansion will strengthen our global competitiveness and increase our market awareness of being a CMO partner of first choice all the way down from early clinical trials up to approval and market supply with a wide range of manufacturing technologies to offer” explains Frank Ternes, Chief Business Officer at Rentschler.
In the last few years, Rentschler has been heavily investing in single-use technology and only recently announced that it will add a new 2,000 L single-use bioreactor. Nevertheless, manufacturing in stainless steel is far from being outdated. Rentschler is experiencing a high demand for stainless steel bioreactor capacity, mainly for market supply, but also for late clinical phases. The criteria for bioreactor selection includes the characteristics of the product to be manufactured, the approval phase, the expected volume requirements, the required flexibility, and competitive pricing due to optimal technological fit.
Rentschler is a CMO with over 35 years proven track record in biopharmaceuticals. Focused on the utilization of mammalian cell lines, Rentschler’s long history covers the development and production of recombinant proteins in compliance with international GMP standards. Rentschler’s customized solutions range from supporting drug candidate selection, cell line and process development capabilities as well as GMP production to comprehensive analytics and fill & finish. Rentschler’s state-of-the-art manufacturing facility includes bioreactors up to 3,000 L and aseptic filling lines for vials (including lyophilization) and prefilled syringes. Our long-term experience with international regulatory affairs and authorities complements the offerings. Rentschler’s full-service concept allows flexibility on the individual project requirements.
Dr. Marion Schrader
Senior Director Marketing
Rentschler Biotechnologie GmbH
Tel.: +49 (0) 7392 701 0