Leading global contract development and manufacturing organization (CDMO) Rentschler Biopharma has broken ground at its new production site, adjacent to its existing site in Milford in the greater Boston area. The new Rentschler Biopharma Manufacturing Center US (RBMC US) is expected to become operational in late 2023. With 22,000 square feet of manufacturing cleanroom space and four new 2,000 L single-use bioreactors, the multi-product facility will significantly expand the company’s U.S. offering in terms of production capacity. Especially for U.S.-based clients, the RBMC US will add much-needed space for the manufacturing of complex molecules and accelerate the clinical and commercial supply of essential biopharmaceuticals.

 

Highly flexible, automated production lines

In keeping with Rentschler Biopharma’s commitment to reducing the complexity of biopharmaceutical manufacturing for its clients, the site is designed to be easily adaptable to meet clients’ changing needs.

The design features upstream ballroom processing sized for production flexibility. The downstream processing suites are equipped with buffer storage and preparation space. The building design can accommodate future adaptations for scale and capacity. Growing with the manufacturing footprint, the site will include expanded quality control (QC), development, and warehousing capabilities.

Dr. Frank Mathias, CEO of Rentschler Biopharma SE, said: “With Rentschler Biopharma’s contribution to the production of mRNA vaccines to beat the COVID-19 virus, we have seen firsthand how important it is to have highly adaptable capacity and to have the experience and expertise needed to produce new therapeutic modalities, fast.”

 

State-of-the-art services and digitalization technologies

The new state-of-the-art facility will be highly automated and leverage industry 4.0 solutions. It will provide innovative digital and analytical services, such as advanced analytics yield optimization, augmented/virtual reality-enabled operations and no-touch batch releases.

Dr. Martin Kessler, CEO of Rentschler Biopharma Inc., the wholly owned U.S. subsidiary, added: “We are excited to significantly expand our U.S. facility to effectively service our clients’ growing needs. This is a very timely step, as the biopharma CDMO market is expected to grow by double digits over the next years, and RBMC US will play a pivotal role in our plans to continually outperform the overall market development. This new site will double our commercial cGMP manufacturing capacity. By bringing in state-of-the-art technology and industry 4.0 solutions, RBMC US will strongly enhance our value proposition in commercial manufacturing.”

 

 

 

 

 

Resource

Rentschler Biopharma (2021, August 12): Rentschler Bioparma breaks ground at new U.S. production site in greater Boston [press release].