Rentschler Biopharma, a biopharmaceuticals CDMO, has broken ground at a production site adjacent to its existing site in Milford, MA in the greater Boston area. The manufacturing centre will add 22,000 sqft of manufacturing cleanroom space and house four 2000 L single-use bioreactors. In keeping with the company’s commitment to reducing the complexity of biopharmaceutical manufacturing for its clients, the site is designed to be adaptable to meet clients’ changing needs, and is expected to become operational in late 2023.
The design features upstream ballroom processing sized for production flexibility, while downstream processing suites are equipped with buffer storage and preparation space. The building design can also accommodate future adaptations for scale and capacity. The site will include expanded quality control (QC), development, and warehousing capabilities. It will be highly automated and leverage industry 4.0 solutions, Rentschler says. This will include digital and analytical services, such as advanced analytics yield optimisation, augmented/virtual reality-enabled operations and no-touch batch releases.
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. The US expansion we have kicked off at the groundbreaking is part of our ongoing plan to strategically grow our business as we support our clients in developing and manufacturing even highly complex molecules. We must always be ready to meet the ongoing and ever-changing challenges of reliably bringing new treatments to patients.”
Dr Martin Kessler, CEO of Rentschler Biopharma Inc., the wholly owned US 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.”
The site will significantly expand the company’s US offering in its capacity and diversity of projects. The current Milford site has gone from a single-product commercial facility to producing multiple products in up to 500 L bioreactor set up. The company also has been adding to its team in Milford. The additional facility will add more space for manufacturing, as well as enabling US operations to centralise support services.
Karen Savage, VP and Milford Site Head, said: “I am so proud of our team and the incredible work they have done, both in terms of continuing production for our existing projects throughout the pandemic, as well as laying the groundwork for making our new site a reality. It is truly gratifying to know that our work at Rentschler Biopharma is such a critical part of offering the best solutions to our client partners and their patients.”