Rentschler Biopharma Contributes to Nearly 25% of FDA-Approved Biopharmaceuticals in 2023

In 2023, the US FDA’s Center for Drug Evaluation and Research (CDER) approved 55 new drugs, 17 of which were biopharmaceuticals. Rentschler Biopharma SE, a leading contract development and manufacturing organization (CDMO) for biopharmaceuticals, including advanced therapy medicinal products (ATMPs), contributed to four, which equals nearly 25%, of these biopharmaceuticals.

Federico Pollano, Senior Vice President Business Development at Rentschler Biopharma, commented “Guiding a promising therapy from its initial clinical trials to commercialization is a demanding endeavor that spans numerous years of development efforts. We provide clients with world-class solutions along the entire biopharmaceutical value chain from bioprocess development to manufacturing and regulatory support. These recent approvals illustrate our capability to support our client partners through this entire and challenging process, emphasizing the importance of our expertise and flexibility to match unique client needs.”

Currently, Rentschler Biopharma is manufacturing a total of eight market approved biopharmaceuticals for its clients, including complex formats such as bispecific antibodies, as well as recombinant enzymes. Rentschler Biopharma’s involvement in successfully bringing these therapeutics to the market underpins the company’s strategic role in developing innovative treatments for patients suffering from cancer, autoimmune disorders, as well as rare diseases. For the four newly approved products, Rentschler Biopharma provided support with integrated capabilities, including consulting, regulatory services, process development, technology transfer and manufacturing. These collaborations involved international clients, showcasing the company’s global reach and excellence across its manufacturing sites.

Benedikt von Braunmühl, CEO of Rentschler Biopharma, said “At Rentschler Biopharma, we strive to create value sustainably, together with our client partners, for patients with serious and rare diseases worldwide. Market approved products truly serve those patients and their caregivers by bringing them new therapeutic options. I am very grateful and proud that our company continuously makes important contributions in the development and manufacturing of innovative biopharmaceuticals and in realizing our clients’ ideas. My sincere gratitude goes to our cross-site teams for their integral contributions to this significant milestone and for their dedication, which is reflected in every aspect of our work.”

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. Rentschler ATMP Ltd., located in Stevenage, UK, is dedicated to cell and gene therapies. For more information, visit www.rentschler-biopharma.com/.