Rentschler Biopharma broke ground at its new production site, adjacent to its existing site in Milford, MA in the greater Boston area. The new Rentschler Biopharma Manufacturing Center US (RBMC US) will add 22,000-square-feet of manufacturing cleanroom space and house four new 2,000L single-use bioreactors.

In keeping with the CDMO’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, notes Frank Mathias, PhD, CEO or Rentschler Biopharma. The RBMC US is expected to become operational in late 2023.

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, according to the company.

Expanded quality control development and warehousing capabilities

Growing with the manufacturing footprint, the site will include expanded quality control (QC), development, and warehousing capabilities. The new state-of-the-art facility also will be highly automated and leverage industry 4.0 solutions, adds Mathias. It will provide digital and analytical services, such as advanced analytics yield optimization, augmented/virtual reality-enabled operations and no-touch batch releases.

“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,” says Mathias. “The U.S. 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.”

“This new site will double our commercial cGMP manufacturing capacity,” points out Martin Kessler, PhD, CEO of Rentschler Biopharma, Inc., the wholly-owned U.S. subsidiary. RBMC US will strongly enhance our value proposition in commercial manufacturing.”

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, both in terms of numbers and expertise. The new facility will add much-needed space for manufacturing, as well as enabling U.S. operations to centralize support services that are essential for seamless production, says Kessler.