Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO), focused exclusively on client projects.
From its headquarters in Laupheim, Germany, and its site in Milford, MA, USA, Rentschler Biopharma offers process development and manufacturing of biopharmaceuticals. The company’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients. Rentschler Biopharma is a family-owned company with about 1,000 employees.
Rentschler Biopharma’s end-to-end offering includes biopharmaceutical process development and manufacturing as well as related consulting activities. Rentschler Biopharma also provides project management and regulatory support. With a focus on mammalian cell lines, Rentschler Biopharma is highly experienced in the development and cGMP manufacturing of monoclonal antibodies, fusion proteins, and other therapeutic proteins in compliance with international standards (EMA/FDA).
Working collaboratively with its clients, the company provides customized solutions with optimized work packages for each development stage. State-of-the-art cGMP facilities and cell culture processes allow manufacturing for both, clinical studies and commercial supply. Ongoing monitoring of the international regulatory landscape and in-depth understanding of the necessary regulatory documentation (CMC) ensures that each project is properly documented in accordance with regulatory requirements.
Rentschler Biopharma’s strategic alliance with LEUKOCARE AG offers best-in-class formulation development considered at every step of the biopharmaceutical development and manufacturing process. The rational and tailored process applies a maximum design space, incl. LE UKOCARE‘s proprietary Stabilizing and Protecting Solutions (SPS®), resulting in products with superior formulations and administration routes. This comprehensive database-driven approach and algorithm-based formulation selection provide clients significant competitive advantages, enabling them to exploit the full commercial potential of their products.
Rentschler Biopharma’s new U.S. site, located in Milford, MA, is currently being qualified as a multi-product facility, offering clients innovative solutions for the bioprocessing development and manufacturing of complex and difficult-to-manufacture proteins, such as multispecific antibodies. The first step in establishing Rentschler Biopharma’s center of excellence in North America is a 500 L single-use bioreactor that will be operational by mid-2020. The next steps include another building for large-scale SU manufacturing and lab capacity for new therapeutic modalities. The company plans to leverage its expertise for client projects through every phase, be it early stage development or clinical and commercial production.
For further information, please visit www.rentschler-biopharma.com.