August 1, 2011
Rentschler Biotechnologie GmbH is a full-service contract manufacturer with over 35 years of experience in the development, production, and approval of biopharmaceuticals in compliance with international GMP standards with a highly skilled staff of 650. 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. Rentschler Biotechnologie is a pioneer in the development and production of biopharmaceuticals — it was the first company in the world to gain market authorization for an interferon-containing drug.
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 Biotechnologie 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 Biotechnologie 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 in owned facilities and a trusted preferred partnership agreement with Boehringer Ingelheim for a seamless project transfer to large-scale manufacturing of up to 15,000 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 fermenters, two 1,000-L single-use bioreactor lines are available.The first single-use facility went in operation mid 2010, and the second will go in operation in October 2011. Our experience with international regulatory affairs and authorities speeds up the time to market and ensures the market success of your product.
Rentschler Biotechnologie’s GMP certified services include
Cell line and process development
Production of active pharmaceutical ingredients
Stainless steel bioreactors: 30 L to 2,500 L
Single-use bioreactors: 250–1,000 L
Cultivation methods: batch, repeated batch, fed batch, and continuous (e.g., perfusion)
Fill and finish
Aseptic filling of vials: lyophilization, terminal sterilization, 0.25–50 mL volumes, up to 70,000 vials/batch
Filling line for small batch sizes and development work
Aseptic filling of prefilled syringes: 0.5–20 mL volumes, up to 15,000 prefilled syringes/batch
Analytics and quality control
Marketing authorization application and consulting
Quality assurance
Corporate project management.
About the Author
Author Details
Dr. Manfred Papaspyrou is vice president of marketing and sales for Rentschler Biotechnologie GmbH, Erwin-Rentschler-Straße 21, 88471 Laupheim, Germany; 49-7392-701-555; [email protected]; www.rentschler.de.
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