Rentschler Biopharma and Leukocare extend service offering with joint U.S. site

Rentschler Biopharma SE, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, and Leukocare AG, a German biotechnology company specialized in the field of biopharmaceutical formulation development, celebrate the fourth anniversary of their unique strategic alliance. Established in 2017 and recently expanded into the U.S., this highly successful alliance integrates best-in-class and tailored formulation development into every step of the manufacturing process and helps to efficiently address the challenges of increasingly complex biopharmaceuticals. Clients benefit from this alliance through shorter development timelines, cost savings and potentially additional patent protection, leading to a competitive edge and enhanced client satisfaction.

During these past four years, the alliance has successfully completed a large number of projects for companies around the globe. The project areas range from established monoclonal antibodies to innovative multispecific formats, as well as novel enzymes and scaffolds. They include both early- and late-stage development programs, highlighting the adaptability and flexibility of tailored services offered by the partnership. With the recent opening of Leukocare’s U.S. development labs and offices at Rentschler Biopharma’s facility in the Greater Boston area, the two companies will work together closely and seamlessly in the U.S. as well as in Europe.

Dr. Frank Mathias, CEO of Rentschler Biopharma SE, commented: “Our strategic alliance with Leukocare is a great success for our two companies and, importantly, for our clients. Formulation issues often lead to the failure of drug development projects or significant delays both in early and late clinical stage, making formulation a critical success factor. Drug development and formulation need to cooperate, and, together, our two companies can address client needs in early- or late-stage development, as well as in commercial manufacturing optimization. We are delighted that this alliance now has a solid footprint in both Europe and the U.S.”

Michael Scholl, CEO of Leukocare AG, added: “Both of our companies are highly focused on not just meeting but exceeding client expectations. Already four years ago, we recognized an increasing demand for advanced and accelerated formulation development services combined with excellent CDMO services. We are excited to expand our presence into the U.S., enabling us to work closely with Rentschler Biopharma on both sides of the Atlantic to provide optimal solutions and customized services for each joint project. We very much look forward to continuing this strong and highly fruitful partnership.”

Biopharmaceuticals are becoming increasingly complex, bringing new challenges in both biomanufacturing and formulation development. Rentschler Biopharma and Leukocare have solved many complex challenges through innovation, cutting-edge technology, and their teams’ extensive expertise. Formulation development projects within the alliance included: adjustment of existing formulations and creation of novel formulations for improving stability or extension of storage time at room temperature. Integrating formulation development know-how in downstream processing often creates additional benefits for clients, e.g., by increasing product yield. The coming together of world-class capabilities in formulation development and high-quality biomanufacturing offer best-in-class project delivery for clients along the entire biopharmaceutical value chain.

About Leukocare AG

Leukocare AG, located in Martinsried/Munich, Germany and Milford, MA, USA, is a biotechnology company specialized in the field of biopharmaceutical formulation development. Operating at the interface of drug substance and drug product development, Leukocare combines sound knowledge of formulation development with bioinformatics and artificial intelligence. The formulation development approach consists of two elements: a library of up to 100 different regulatory well-established and employed excipients and a rational development approach which employs statistical software and self-learning algorithms as well as state of the art design of experiment (DoE) matrices. By utilizing the artificial intelligence elements, Leukocare is able to specifically combine excipients leading to stabilizing formulations tailored to the drug product’s needs. Leukocare’s superior and innovative drug product formulations can be applied to a broad range of applications: biologics & biosimilars, vaccines & viral vectors and biofunctionalized devices.

About the Rentschler Biopharma and Leukocare alliance

Launched in 2017, the global alliance between Rentschler Biopharma SE and Leukocare AG aims at integrating formulation development strategically into every step of biopharmaceutical value chain. Working closely with the client ensures a tailored and best-in-class approach for the client’s drug product. This innovative approach offers clients significant competitive advantages, enabling them to optimize time-to-market and exploit the full commercial potential of their products and markets.