Rentschler Biotechnologie GmbH

Rentschler is a full-service Contract Development and Manufacturing Organization (CDMO) and one of the leaders in the industry. Focused on the process development and manufacturing of biopharmaceuticals in mammalian cell culture, we support our global clients through to market approval of their products. Thanks to many years of experience, our outstanding expertise in finding solutions and our flexibility, we can react quickly and effectively to client requirements. Our success is underpinned by our focus on product quality, on-time delivery as well as comprehensive and tailored consulting and project management. Founded in 1927, Rentschler is a privately owned medium-sized company headquartered in Laupheim, Germany.

The success of a project starts with detailed and reliable consulting and planning. Our experience covers the cell line and process development and manufacturing of recombinant proteins such as monoclonal antibodies, fusion proteins and enzymes in compliance with international cGMP standards (EMA/FDA). cGMP certified suites with stainless steel bioreactors up to 3,000 L and single-use bioreactors with up to 2,000 L, support the cost-efficient manufacturing and purification of material. Liquid aseptic filling in vials completes our portfolio. Each manufacturing process is scalable for clinical studies as well as for market supply. Our quality control including analytical characterization and stability studies ensures safety, purity and stability of the product. Finally, development of optimized strategies for approval and creation of approval documents ensure that each project is documented in accordance with international regulatory requirements.