USA: Production of Complex Molecules Rentschler Biopharma Breaks Ground for Production Facility in the USA

A new facility at Rentschler Biopharma's existing site in Milford, USA, is expected to significantly expand the company's cGMP production capabilities and accelerate the clinical and commercial supply of biopharmaceuticals. The site will feature highly flexible, automated production lines and offer state-of-the-art services and digitization technologies.

Laupheim; Milford/USA — Contract development and manufacturing organization (CDMO) Renschler Biopharma, has broken ground at its new production site, adjacent to its existing site in Milford, USA in the greater Boston area. The new Manufacturing Center US (RBMC US) will add 22,000 square feet of manufacturing cleanroom space and house four new 2000 L single-use bioreactors. The site is designed to be easily adaptable to meet clients’ changing needs. 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. Growing with the manufacturing footprint, the site will include expanded quality control (QC), development, and warehousing capabilities. Importantly, this 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.

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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 new site will significantly expand the company’s U.S. offering in terms of 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 talented 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..

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