In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|November 7, 2019
Rentschler Biopharma to Launch US Center of Excellence
Author(s)BioPharm International Editors
The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility.
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Rentschler Biopharma, a Germany-based contract development and manufacturing organization (CDMO), announced it is opening a center of excellence in Milford, MA, to expand its US footprint. The new addition will also launch a single-use bioreactor for the 93,000-ft2 facility, according to a Nov. 6, 2019 Rentschler press release.
The new XDR-500 bioreactor is equipped with a working volume of 100–500 L, downstream process capabilities of 2–8 g/L, and is part of the state-of-the-art GMP facility suite concept, according to the release. The system is set to be client-ready in mid-2020.
Additionally, the company is planning on adding a separate building to the site for large-scale and single-use manufacturing, and lab capacity for new modalities.
Dr. Jesús Zurdo, senior vice-president, Innovation and Venture Partnerships at Rentschler, will present the company’s clinical and commercial manufacturing capabilities at BIO-Europe from Nov. 11–13 in Hamburg, Germany.
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