Overview
Rentschler Biopharma is a global leading CDMO specializing in full-service bioprocess development and cGMP manufacturing of high-quality biopharmaceuticals, including complex biologics and recombinant proteins. With over 50 years of experience, they offer expertise in process optimization, analytical and formulation development, and client program management across state-of-the-art facilities. Recent expansions include new production lines in Milford, Massachusetts, and buffer media manufacturing in Laupheim, Germany, to meet growing demand.
Frequently asked questions
- What services does Rentschler Biopharma provide?
- They offer full-service CDMO solutions including bioprocess development, analytical development, formulation development, cGMP manufacturing, and fill & finish services, with expertise in complex biologics and difficult-to-express proteins.
- What are their manufacturing capabilities and locations?
- Facilities include expanded cleanroom space with 2,000-liter single-use bioreactors in Milford, Massachusetts, USA, and a new buffer media production plant in Laupheim, Germany, supporting cell culture-based therapeutic proteins.
- What regulatory experience do they have?
- They contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023, with strict virus safety measures, process characterization, and cGMP compliance across their global operations.