Rentschler provides customized, integrated biopharmaceutical cGMP contract manufacturing services, from mammalian cell line and clinical trial to marketing authorization, from pharmaceutical API production to fill and finish.

Rentschler Biotechnologie GmbH is part of the Rentschler Group based in Laupheim, Germany. As an international full-service cGMP pharmaceutical contract manufacturing provider with a highly skilled staff of 450, Rentschler Biotechnologie has more than 30 years of experience in the development, production and approval of biopharmaceuticals in compliance with international cGMP standards. Regulatory advice and fill and finish are part of the company's service range. Currently Rentschler has nine stand-alone GMP suites with volumes of 30 L, 250 L, 500 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.

Established expertise: Rentschler Biotechnologie is a cGMP pharmaceutical contract manufacturing company like no other.

The range of comprehensive cGMP contract manufacturing services offered by Rentschler Biotechnologie, based on 30 years of experience, will turn your vision of a successful biopharmaceutical product into reality - rapidly and reliably. Your investment in a partnership with Rentschler Biotechnologie will ensure the success of your biotech project. You can trust the know-how of this biotechnology pioneer, from cell culture development to clinical trial all the way to the finished product.

Place your project in our capable hands - A.C.T. now:

Advanced Service | Competence | Time-to-market

From mammalian cell line to the development and production of the active pharmaceutical ingredient, API, from marketing authorization to fill and finish, Rentschler cGMP contract manufacturing offers everything you need whenever you need it.

Rentschler is flexible when it comes to cGMP pharmaceutical contract manufacturing services, capacity and products. For process development, production of materials for clinical research trials and the market - whether it is low-dose cytokines or high-dose antibodies and biosimilars.

The advantage: All cGMP pharmaceutical and biotech contract manufacturing services leading up to the launch of your new drug from one qualified source

You benefit from having a responsible and experienced partner to implement your project goals, coordinate operations and provide you with regular progress updates. Rentschler Biotechnologie saves you valuable time on the path of your product to the market. Rentschler's cGMP contract manufacturing experience with FDA and EU international regulatory affairs and authorities speeds up the time to market and ensures the market success of your biotech product.

Rentschler Biotechnologie has the cGMP contract manufacturing capacity to handle up to fourteen individual biotech customer projects. We will continue to expand and improve our facilities to the advantage of your new and challenging biotech projects.

cGMP certified biopharmaceutical and API contract manufacturing services provided by Rentschler Biotechnologie:

• Cell Culture Line and Process Development
  
• Contract Production of Active Pharmaceutical Ingredients (API)
  
• Fill and Finish
  
• Analytics and Quality Control
  
• FDA and EU Regulatory Affairs
  
• Quality Assurance
  
• Corporate Project Management

Capacities up to 2,500 L in owned facilities and a trusted preferred partnership agreement with Boehringer Ingelheim for a seamless project technology transfer to large-scale manufacturing of up to 15,000 L assure development and planning security throughout the whole drug development process - from clinical trial phases up to the market production. Our biopharmaceutical experience with FDA and EU international regulatory affairs and authorities speeds up the time to market and ensures the market success of your biopharmaceutical or API product.

For all North American cGMP biopharmaceutical API or Fill and Finish contract manufacturing enquiries, please use the following contact information:

Rentschler Inc.
510 Broad Hollow Road, Suite 209
Melville, NY 11747, USA

International Sales Director
Dr. Roland Hecht
Phone. +49(0)7392/701-441
Fax: +49(0)7392/701-521
Email: biotech.us@rentschler.de

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