Company Category: cGMP Manufacturing (Drug Product)

Rentschler Biopharma is a leading contract development and manufacturing organization offering bioprocess development and cGMP manufacturing of biopharmaceuticals and related consulting activities, including project management and regulatory support. Rentschler Biopharma is a family-owned company with about 1,200 employees, headquartered in Laupheim, Germany, with a second site in Milford, USA, and an affiliate dedicated to cell and gene therapies in Stevenage, UK. | Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO), offering process development and cGMP manufacturing of biopharmaceuticals, including adeno-associated virus (AAV) gene therapies, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma is a family-owned company with about 1,200 employees, headquartered in Laupheim, Germany, with a second site in Milford, USA, and an affiliate dedicated to cell and gene therapies in Stevenage, UK. | Rentschler Biopharma is a global 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, 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 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 operations in Milford, MA, USA. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma’s focus on sustainability. Rentschler Biopharma brings 50-years of biopharmaceutical CDMO experience in the development and cGMP manufacturing of advanced antibodies and complex proteins, monoclonal antibodies, fusion proteins, recombinant enzymes, as well as advanced therapies. We have leveraged our proven experience top serve more than 170 clients worldwide in compliance with international standards (EMA/FDA). At Rentschler Biopharma, “reliability you can trust” is more than a promise – It’s our commitment. We take pride in our contribution to nearly 25% of FDA-approved biopharmaceuticals in 2023. Working collaboratively with our clients, Rentschler Biopharma provides customized solutions with optimized work packages for each development stage. State-of-the-art cGMP facilities and cell culture processes allow manufacturing for both clinical studies and commercial supply. Ongoing monitoring of the international regulatory landscape and in-depth understanding of the necessary regulatory documentation (CMC) ensures that each project is properly documented in accordance with regulatory requirements. Bioprocess development – Fast and efficient supply for multiple candidate screening – Robust and scalable CHO cell lines for cGMP manufacturing – Efficient cell culture and purification processes for any protein format – Well-established analytical methods – Advanced formulation development cGMP biomanufacturing – Multiple stainless steel bioreactor lines, including a twin system with 2x 3,000 L, flexible single-use bioreactor lines up to 2,000 L – New state-of-the-art production line with 4 x 2,000L single-use bioreactors in Milford, MA, USA – State-of-the-art purification processes – Guaranteed product quality and purity in accordance with cGMP guidelines As a world-class solution provider, with over 50 years of experience, we ensure optimum time-to-clinic and time-to-market by accelerating timelines to create a competitive advantage for our clients. For seamless market approval, we consult and assist clients with regulatory queries, develop optimized strategies, and generate complete documentation for approval of clinical studies and market launch.