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High-Performance Biopharmaceuticals Manufacturing

Marion Schrader

August 15, 2014

3 Min Read

BPI_A_141207AR40_O_F0001g.jpgIdentifying 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 a proven track record for over 40 years. 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.

TurboCell™ Technology

Rentschler’s proprietary TurboCell™ platform enables the simultaneous production of up to 20 early stage drug candidate variants in stable CHO cell lines. TurboCell™ is a technology for the fast generation of highly stable recombinant mammalian (CHO-K1) cell lines based on cassette exchange (RMCE). The cassette allows the precise integration of the gene of interest (GOI) at a predefined position with stable expression. This approach enables rapid cell line development and fast supply of material. In a standard 16-day fed-batch cultivation process, sufficient amount of material can be supplied within just six weeks (stable cell pools) or 12 weeks (clonal cell lines) for use in early drug testing and preclinical studies. TurboCell™ is a true innovation-generating stable cell line with predictable growth and production characteristics, and it reduces both project timelines and costs.

Expert Guidance and Solutions

For our clients, the Rentschler brand stands for expert guidance and solutions, long-term expertise, innovation, product quality, and quickest possible time to market. Our success as a contract manufacturer also depends on proactive and responsive communication — the latter being characterized by the science-driven performance of our personnel.

Rentschler uses 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 cell culture process, purification, and formulation development round out the portfolio.

State-of-the-art facilities and services comprising fed-batch, and perfusion processes allow the production of material for clinical phases and commercial supplies. Current good manufacturing practice (cGMP)–certified suites with bioreactors from 30 L to 3,000 L ensure the flexible and customized production and delivery of material. As a cost-efficient and fast manufacturing alternative to stainless steel bioreactors, single-use bioreactors are available with volumes of up to 1,000 L. Rentschler is one of the first biopharmaceutical contract manufacturers that established a fully integrated disposable process, and we already have more than three years of experience with this system. Finally, our fill–finish facility offers the aseptic liquid filling in vials (100–80,000 units), lyophilization (100–70,000 units), and aseptic liquid filling of prefilled syringes (100–15,000 units).

Independent, Privately Owned, and Highly Flexible

Rentschler is an independent and privately owned company headquartered in Germany. The company’s range of full-service customized solutions support drug candidate selection, cell line and process development over cGMP, and production to fill–finish and analytics.

Our experience with international regulatory affairs and authorities increases the success rate for approval.

In summary, our full-service concept allows us to react with flexibility on the scope of services our clients’ need. Every project with Rentschler is in expert hands.

Dr. Marion Schrader is senior director marketing for Rentschler Biotechnologie GmbH, Erwin-Rentschler-Straße 21, 88471 Laupheim, Germany; 49-7392-701-0; [email protected]; www.rentschler.de.

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