Rentschler Biopharma Announces New State-of-the-Art Production Line in Massachusetts is Fully Operational

Rentschler Biopharma SE recently announced the company’s new state-of-the-art production line, formerly known as the Rentschler Biopharma Manufacturing Center (RBMC), in Milford, MA, is now fully operational. The company has a major project underway at the new line, with several additional projects in the pipeline, and continues to welcome new projects and clients.

The new production line is the largest investment in Rentschler Biopharma’s more than 150-year history. The groundbreaking took place in August 2021, during the COVID-19 pandemic, and the first engineering run of a 2,000L batch has been recently completed. With this, the line is now fully up and running. The multi-product facility, which doubles Rentschler Biopharma’s global cGMP capacity, is focusing mainly on commercial production of highly complex molecules. The original Milford site went from a single-product commercial facility to producing multiple products in an up to 500L bioreactor setup. The new production line has added 22,000 square feet of manufacturing cleanroom space and houses four new 2,000L single-use bioreactors, bringing the total of production lines at the site up to three.

Benedikt von Braunmühl, CEO of Rentschler Biopharma SE, said “As a fifth-generation, family owned company, we stand at the forefront of manufacturing innovative therapies for patients with serious and rare diseases worldwide. The completion of our new, state-of-the-art production line is an important milestone for our company and emphasizes Rentschler Biopharma’s strong capabilities in the US. Our clients are our partners, and we are working with them to empower tomorrow’s therapies today. Indeed, in 2023, Rentschler Biopharma was proud to contribute to nearly 25% of the biopharmaceuticals approved by the US FDA. I would like to thank our teams on both sides of the Atlantic who worked tirelessly together to get this important facility online.”

Tom Roberts, President of Rentschler Biopharma Inc. and General Manager US, added “Our new line is vital to growing our business and effectively serving the U.S. market, and I am excited about bringing in new clients as well as expanding our support of existing ones with a reliability they can trust. I also would like to extend my gratitude to the entire team for their strong support in getting this important new production line up and running. We are embarking on a new stage in our long and successful history and are poised to tackle the most complex challenges in biopharmaceutical development and manufacturing. In light of evolving industry legislation, we remain committed to supporting our clients responsibly and contributing positively to both national interests and global health advancements.”

Rentschler Biopharma acquired the Milford site in 2019. Since then, the company has transformed the facility into a multi-product manufacturing site, expanding it from 93,000 square feet to 138,000 square feet in total. Earlier this year, the company received the Gold Award for the Central Massachusetts region in the 20th Annual Team Massachusetts Economic Impact Awards for its significant contributions to job growth, facility expansion, investment, and community engagement.

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, including adeno-associated virus (AAV) gene therapies, as well as related consulting activities, 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. Rentschler Biopharma is a family-owned company with about 1,400 employees, headquartered in Laupheim, Germany, with a second site in Milford, MA, USA. A third site, located in Stevenage, UK, is dedicated to advanced therapies. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma’s focus on sustainability. For more information, visit www.rentschler-biopharma.com.