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registry of biomedical companies

 
  September 30, 2016
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Registry of biomedical companies:

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Rentschler Biotechnologie GmbH

Erwin-Rentschler-Str. 21
Laupheim 88471 Germany
Germany

Phone: +49 7392 701-0
Fax: +49 7392 701-300
E-Mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

Description:

Rentschler is a Contract Development and Manufacturing Organization (CDMO) with over 40 years’ experience in manufacturing of biopharmaceuticals. As an independent and privately-owned company headquartered in Germany, we make a crucial contribution to the global availability of biotechnological pharmaceuticals. Our full-service customized solutions range from cell line, bioprocess, analytic methods, and formulation development over production to analytical testing services and fill & finish.

Focused on mammalian cell lines, our experience covers the development and manufacturing 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.

State-of-the-art facilities and services comprising fed-batch, continuous, and perfusion processes allow the production of material for clinical phases and commercial supplies. GMP certified suites with stainless steel bioreactors from 30 L up to 3,000 L ensuring the flexible and customized production and delivery of material. As a cost-efficient and fast manufacturing alternative, Rentschler provides also single-use bioreactors with volumes of up to 2,000 L. Our Fill & Finish facility offers the aseptic liquid filling in vials (100 up to 80,000 units), lyophilization (100 up to 70,000 units) and aseptic liquid filling of prefilled syringes (100 to 15,000 units).

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). This approach enabled fast supply of sufficient amount of material within just six weeks (stable cell pools) or twelve weeks (clonal cell lines).

Our experience with international regulatory affairs and authorities increases the success rate for approval. This reduces not only the time-to-market but supports the success of your project. The Rentschler brand stands for expert guidance and solutions, long-term expertise, innovation, independence, quality and quickest possible time to market.
In summary, our full-service concept allows us to react with flexibility on the scope of services our clients need.



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Last update of this entry: August 28, 2015

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