German CDMO Rentschler Biopharma SE has put into operation a single-use bioreactor for the 93,000 square foot facility in Milford, Massachusetts, in the Greater Boston area (US). The move, the company said, is the first step in an expansion project to grow its US footprint and establish a Centre of Excellence in North America.
The XDR-500 bioreactor, with a working volume of 100-500L and downstream process capabilities of 2-8 g/L, is part of the state-of-the-art GMP facility suite concept.
The system is planned to be client-ready in mid-2020 and is currently being prepared for technology transfer.
Rentschler said the Milford site is already taking on new projects, including complex and difficult-to-manufacture proteins, such as multispecific antibodies.
Expansion plans
Rentschler also revealed further expansion planning includes another building for large-scale manufacturing, which will also be single-use bioreactor manufacturing as well as lab capacity for new modalities.
For Rentschler, the combined European and US operation is aligned with its client-centric approach for advanced technologies to facilitate the robust and scalable production of complex biomolecules.
The news comes four weeks after Rentschler's announcement of the collaboration deal with Summit Pharmaceuticals that will see the German CDMO enter Japan.