Rentschler Biopharma breaks ground at new U.S. production site in greater Boston

• New facility, adjacent to existing Milford, MA site, to significantly expand cGMP manufacturing capacity, accelerating clinical and commercial supply of essential biopharmaceuticals
• Site will employ highly flexible, automated production lines plus state-of-the-art services and digitalization technologies
• Multi-product facility to focus on commercial production of complex molecules for U.S.-based clients

Laupheim, Germany and Milford, MA, USA, August 12, 2021 - Rentschler Biopharma, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, announced that the company has broken 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 2,000 L single-use bioreactors. 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 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.

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 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."

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."

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.

Karen Savage, Vice President and Milford Site Head, noted: "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."

About Rentschler Biopharma SE
Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals as well as related consulting activities, including project management and regulatory support. Rentschler Biopharma's high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy and advanced technologies ensure product quality and productivity at each development and manufacturing step. In order to offer best-in-class formulation development along the biopharmaceutical value chain, the company has entered into a strategic alliance with Leukocare AG. Rentschler Biopharma is a family-owned company with about 1,000 employees, headquartered in Laupheim, Germany, with a second site in Milford, MA, USA. In Stevenage, UK, Rentschler Biopharma has launched a company dedicated to cell and gene therapies, Rentschler ATMP Ltd.

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