CDMO Rentschler is adding a 500 L single-use bioreactor at the plant it acquired from Shire in January and says further expansions will add manufacturing and lab capacity.
Rentschler completed the acquisition of the Milford, Massachusetts biomanufacturing facility from the now defunct Shire in January 2019, marking its first step into the US.
The German contract development and manufacturing organization (CDMO) makes the recombinant hemophilia A product Obizur form the facility for Takeda – which bought Shire earlier this year – but a Rentschler spokesperson said a three-phase expansion project has begun in efforts to grow its US client base and establish a Center of Excellence in the US.
“We recently purchased a 500 L single-use bioreactor for the 93,000 square foot Milford facility,” Cora Kaiser told Bioprocess Insider. “The bioreactor is a critical component in transforming the site from a single product to a multi-product facility, and we are in the qualification process for this.”
She added that this is the first bioreactor for the site, which has previously used only roller bottle technology, and it will be available for customers in the second quarter of 2020.
“We are excited about this first part of our expansion plans, as the site, with our highly flexible business model, is already taking on new projects, including multi-specific antibodies. We are in close contact with a number of interested clients and have recently started reconstruction work for the next project.”
But plans are afoot to add more bioreactors, Kaiser said with another building based on single-use bioreactors and flexible use of multiple processing technologies in the works. And, she added, in a third phase Rentschler is “looking to add GLP/GMP lab capacity to offer services for new modalities.”
Financial details have not been divulged, but to serve the expansions and its clients needs, the CDMO is in “hiring mode,” Kaiser said.
“Since the acquisition, we have increased staff by 15% percent and continue to hire.” About 70 staff worked at Milford when the plant was acquired in January.