Rentschler Biopharma lays the foundation stone for a new US production facility in the greater Boston area
Rentschler Biopharma New cGMP manufacturing facility
New Rentschler Biopharma facility at the existing facility in Milford, MA, USA will significantly expand cGMP manufacturing capabilities and accelerate the clinical and commercial supply of vital biopharmaceuticals
- The location will have highly flexible, automated production lines and offer state-of-the-art services and digitization technologies
- The multi-product facility focuses on the commercial production of complex molecules for customers in the USA
Laupheim and Milford, MA, USA, August 12, 2021 – Rentschler Biopharma SE, a leading service and contract development company (CDMO) for biopharmaceuticals, announces that the company has broken ground for its new manufacturing facility, which will be located at the existing site in Milford, MA, USA in the greater Boston area. The new Rentschler Biopharma Manufacturing Center US(RBMC US) will have an additional clean room area of approx. 2,050 square meters and accommodate four new 2,000-liter disposable bioreactors. In order to reduce the complexity of biopharmaceutical production for Rentschler Biopharma’s customers, the system is designed in such a way that it can be easily adapted to changing customer needs. The RBMC US is expected to go into operation at the end of 2023.
The plans for the plant envisage a modern large room for flexible upstream processing . The areas intended for downstream processing are equipped with rooms for preparing the processes and storing buffers. The building design allows for future adjustments in terms of size and capacity. The manufacturing facility will include expanded quality control (QC), development and warehousing capabilities. The new, state-of-the-art facility will be highly automated and use Industry 4.0 solutions. This includes innovative digital services and analyzes, such as B. Analytics to optimize the yield, monitoring of processes with augmented / virtual reality and contactless batch release.
Dr. Frank Mathias, CEO of Rentschler Biopharma SE, said: “Rentschler Biopharma’s contribution to the manufacture of mRNA vaccines against the COVID-19 virus has shown us the importance of having highly adaptable production capacities. Experience and a high level of technical know-how are also essential in order to be able to produce new therapeutic modalities quickly. Our further expansion in the USA, which we initiated with the laying of the foundation stone, is part of our strategic plan to expand our business with the aim of providing our customers with the best possible support in the development and manufacture of highly complex molecules. We are ready to face the ongoing and constantly changing challenges in order to reliably provide new therapies to patients. “
Dr. Martin Kessler, CEO of the US subsidiary Rentschler Biopharma Inc., added: “We are pleased about this large-scale expansion of our US location in order to effectively serve the growing needs of our customers. This step comes at exactly the right time, as the CDMO market for biopharmaceuticals is expected to grow at double-digit rates over the next few years. RBMC US plays a central role in our plans to continue to outperform the market. With this new system, which has the latest technology and Industry 4.0 solutions, we are doubling our cGMP production capacity and significantly expanding our range of services in commercial production. “
The current location in Milford has already been developed from a commercial facility specializing in one product to a multi-product facility with bioreactors with a capacity of up to 500 liters. The company has also expanded its experienced team in Milford, both in terms of personnel and expertise. The new facility will now significantly expand the company’s offering in the United States in terms of capacity and variety of projects. This expansion creates urgently needed additional production capacities and also enables customers based in the USA to bundle the services required for smooth production in a single source.
Karen Savage, Vice President and Head of Milford, said, “I am proud of our team and the great work they do. With continuous production for our existing customers, we have achieved a lot during the pandemic. At the same time, we have laid the foundations for the realization of our new location. The fact that our work at Rentschler Biopharma makes such a decisive contribution to offering our customers and their patients the best solutions is highly motivating for all of us. “