August 1, 2012
Rentschler Biotechnologie GmbH is a global, full-service contract manufacturer with over 35 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards (EMA/FDA). As part of the Rentschler Group and headquartered in Laupheim, Germany, Rentschler is one of three leading European CMOs operating globally. Dedicated to delivering high-quality biopharmaceuticals produced in mammalian cell culture, Rentschler has nine stand-alone GMP suites with volumes of 30 L, 250 L, 500 L, 1,000 L, and 2,500 L, which allows producing material for clinical trials and supplying the market. 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. The company is an independent, family-owned business and currently has about 650 employees.
Rentschler Excels with Expertise and Full Service from “Gene to Drug Product”
Rentschler provides customized, integrated biopharmaceutical services: from the cell line to the development and production of the active ingredient and from marketing authorization to fill and finish. To complete its future-oriented technology and service portfolio, Rentschler concluded a cooperation agreement with Cellca GmbH aimed at the development, application, and marketing of a high-level expression system for mammalian cells. The long-standing experience of Rentschler combined with its range of comprehensive services reduces time delays and ensures the success of any project by rapid and reliable execution. Rentschler develops tailored solutions for each customer through all phases of development and production, whether low-dose cytokines or high-dose antibodies and biosimilars.
Rentschler Meets Timelines for Customers’ Success
Rentschler is a responsible and experienced partner for implementing project goals, coordinating operations, and communicating progress updates for high customer satisfaction. Capacities up to 2,500 L ensure development and planning security throughout the whole development process-from clinical phases up to market production. As a cost-efficient and fast manufacturing alternative to the stainless steel bioreactors, two 1,000-L single-use bioreactor lines are available. The first single-use facility started running mid 2010. The second 1,000-L multiproduct manufacturing facility went in operation in October 2011 and won the 2012 Facility of the YearAward (FOYA) in the “Equipment Innovation” category for its design to minimize manufacturing costs and product cycle times. Our experience with international regulatory affairs and authorities speeds up the time to market and ensures the market success of your product.
Rentschler’s full service program include
Corporate project management
Cell line development
Bioprocess development
Production of active pharmaceutical ingredients (APIs) with production capacities in stainless steel bioreactors (3 × 30 L, 1 × 50 L, 2 × 250 L, 2 × 500 L, and 1 × 2,500 L) and single-use systems (2 × 1,000 L)
Formulation, fill and finish with aseptic liquid filling in vials (DIN 2R to 20R and 50-mL vials in batch sizes from 100 up to 80,000 vials) and lyophilized vials (DIN 2R to 20R vials in batch sizes from 100 up to 70,000 vials); aseptic filling of prefilled syringes (from 1-mL to 10-mL volumes in batch sizes of 100 to 15,000 syringes), and labeling and packaging for clinical studies
Quality control
Regulatory affairs
Quality assurance
About the Author
Author Details
Dr. Klaus B. Schoepe is senior vice president client relations for Rentschler Biotechnologie GmbH, Erwin-Rentschler-Straße 21, 88471 Laupheim, Germany;+49-7392-701 -555; [email protected]; www.rentschler.de.
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