Rentschler Biopharma has started operations of its new facility, a single-use bioreactor in Milford, MA, in the Greater Boston area.
The 93,000 square foot XDR-500 bioreactor with a working volume of 100-500L and downstream process capabilities of 2-8g/L, is part of the state-of-the-art GMP facility suite concept.
A fully-integrated system, the XDR Single-Use Bioreactor delivers proven stirred-tank performance across a wide range of cell lines.
The single-use technology eliminates time-consuming and costly Clean in Place (CIP), cleaning validation procedures, and Steam in Place (SIP).
Compared to the fixed stainless steel hard piped vessels, the system's turnkey design enables fast installation and startup as well as rapid batch-to-batch turnover and increased process flexibility.
The system is currently being prepared for technology transfer and is expected to be client-ready by mid-2020.
New projects including complex and difficult-to-manufacture proteins, e.g., multispecific antibodies are already being taken upon by the Milford site.
Further expansion includes another building for large-scale manufacturing will also be single-use bioreactor manufacturing and lab capacity for new modalities.