Rentschler Biopharma SE, a global contract development and manufacturing organization (CDMO) for biopharmaceuticals, has secured a major client for its new Rentschler Biopharma Manufacturing Center (RBMC) facility at its site in Milford, MA. The RBMC is expected to be operational in the second half of 2024.

The company, a long-standing client of Rentschler Biopharma in Germany, has contracted to have its lead product manufactured at the RBMC for clinical supply. The protein therapeutic is seeking to address a form of cancer. Rentschler Biopharma successfully produced cGMP-quality product for early phase clinical testing at its manufacturing site in Laupheim, Germany. The project will now be transferred to the U.S. for additional supply.

The current Milford site has gone from a single-product commercial facility to producing multiple products in an up to 500 L bioreactor set up. The new, state-of-the-art RBMC adds 22,000 square feet of manufacturing cleanroom space and houses four new 2,000 L single-use bioreactors. The expansion will double Rentschler Biopharma’s global cGMP capacity. The facility will mainly focus on commercial production of highly complex molecules for international clients.

Federico Pollano, senior vice president business development of Rentschler Biopharma, said, “We are delighted to have our client place their trust in us to manufacture their product for their continued clinical development. An important aspect of our services is the seamlessness of our operations across sites and our consistent delivery of top-quality products. We strive to be a true partner with our clients and look forward to bringing more projects, from both new and existing clients to our new state-of-the-art U.S. facility.”

Benedikt von Braunmühl, CEO of Rentschler Biopharma, said, “Rentschler Biopharma is committed to reducing the complexity of biopharmaceutical manufacturing for our clients, and our RBMC facility was designed to be easily adaptable to meet clients’ evolving needs as they advance and grow. Today’s announcement highlights the strategic significance of our U.S. operations in growing our international capabilities and reinforces our dedication to being a provider of comprehensive development and production solutions for the biopharmaceutical industry. Moreover, it underlines our commitment to advancing medicine to save lives, together with our clients and partners.”