August 1, 2013
Identifying the most appropriate contract manufacturer that is most likely the best match for your lead pharmaceutical candidate is a true challenge. Rentschler is a biopharmaceutical manufacturer with over 35 years proven track record. Focused on mammalian cell lines, our experience covers the development, production, and aseptic filling of recombinant proteins such as cytokines, enzymes, monoclonal antibodies, and fusion proteins in compliance with international GMP standards (EMA/FDA). We don’t just claim to be reliable and experienced; our many successful projects and long-lasting client relationships show that we are.
Innovative Technology
Rentschler’s proprietary TurboScreen platform enables the simultaneous production of up to 20 early stage drug-candidate variants in stable CHO cell lines. With this technology, the selection of the most suitable drug candidate is very fast and easy. In a standard 16-day fed-batch cultivation process, a sufficient amount of material can be supplied within just six weeks (stable cell pools) or twelve weeks (clonal cell lines) for use in early drug testing and preclinical studies as well as phase 1 clinical trials. TurboScreen is a true innovation, generating stable cell lines with predictable growth and production characteristics while reducing both project timelines and costs.
Science-Driven Performance and Cutting-Edge Technologies
Our success as a contract manufacturer depends on our product quality, on-time delivery, and proactive and responsive communication, the latter being characterized by the science-driven performance of our personnel.
Rentschler employs cutting-edge technologies developed either in house or together with Cellca GmbH as a partner for high-titer expression in mammalian cell lines. High-performance upstream and downstream process development round up the service portfolio.
State-of-the-art facilities and services including batch, fed-batch, and perfusion processes enable the production of material for clinical phases and commercial supplies. Our cGMP-certified suites offer volumes from 30 L up to 2,500 L, ensuring the flexible and customized production and delivery of material. As a cost-efficient and fast manufacturing alternative to stainless-steel bioreactors, Rentschler provides also single-use bioreactors with volumes of up to 1,000 L. Our fill and finish facility offers aseptic liquid filling of vials (100–80,000 units), lyophilization (100–70,000 units), and aseptic liquid filling of prefilled syringes (100–15,000 units).
Independent, Family-Owned, and Highly Flexible
Rentschler is an independent and family-owned company headquartered in Germany. The full-service customized solutions range from supporting drug candidate selection through cell line and process development, cGMP production, analytics, and fill and finish. Our experience with international regulatory affairs and authorities increases the success rate for approval. Not only does this reduce your time to market, but it also supports the success of your project.
In summary, our full-service concept allows us to react with flexibility on the scope of services our clients need.
About the Author
Author Details
Dr. Klaus B. Schoepe is vice president project management for Rentschler Biotechnologie GmbH, Erwin-Rentschler-Straße 21, 88471 Laupheim, Germany;+49-7392-701-0; [email protected]; www.rentschler.de.
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