August 10, 2016
Sponsored by Rentschler Biopharma
Rentschler is a full-service contract development and manufacturing organization (CDMO) and one of the leaders in the industry. Focused on the development and manufacturing of biopharmaceuticals in mammalian cell culture, we support our global clients through to market approval of their products. Delivering successful projects allows us to make an essential contribution to the global availability of biopharmaceuticals. Thanks to many years of experience, the high quality of our consulting services, and our flexibility, we can react quickly and effectively to clients’ requirements. Our success as a CDMO is underpinned by our focus on product quality, on-time delivery, and comprehensive and tailored project management. Founded in 1927, Rentschler is a privately owned medium-sized company headquartered in Laupheim, Germany.
InnovatIve Technology
Rentschler’s proprietary TurboCell™ mammalian expression platform enables the simultaneous production of up to 20 early stage drug candidate variants. The vector construction is based on site-directed integration of genes that allows production of a reproducible and stable cell line. Specifically, this approach enables fast supply of material within just seven weeks (stable cell pools) or fourteen weeks (clonal cell lines) to be used in early drug testing and preclinical studies.
2015
Full-Service Concept
Rentschler’s full-service offering covers all activities from bioprocess development through to manufacturing, analytical characterization and fill and finish. Focused on mammalian cell lines, our experience covers the development and manufacturing of recombinant proteins such as monoclonal antibodies, fusion proteins, cytokines, and enzymes in compliance with international curent good manufacturing practice (CGMP) standards (EMA/FDA). State-of-the-art CGMP facilities and cell culture processes allow us to manufacture material for clinical phases and commercial supplies. Our constant monitoring of regulatory environments and extensive experience in the creation of approval documents at an international level ensures that each project is documented in accordance with regulatory requirements.
Bioprocess Development
Comprehensive expertise in the development of high-performance cell lines
Development, optimization, and validation of cell culture and recombinant protein purification processes
Development of stable liquid formulations for clinical phases
Rapid and flexible development of robust analytical methods.
CGMP Manufacturing
Stainless steel bioreactors up to 3,000 L and single-use bioreactors up to 2,000 L
Fed-batch, continuous, and perfusion processing
State-of-the-art purification processes
Quality control ensuring safety, purity, and stability of products.
Aseptic Filling
Volumes for clinical studies
Aseptic liquid filling in vials and prefilled syringes
Lyophilizates
Labeling and packaging for clinical studies.
Consulting Services
Consulting and planning
Project management
Regulatory support.
Dr. Marion Schrader is senior director of marketing at Rentschler Biotechnologie GmbH, Erwin-Rentschler-Str. 21, 88471 Laupheim, Germany; +49-7392-701-0; [email protected]; www.rentschler.de.
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