Mabion S.A. ("Mabion"), a leading Polish CDMO specializing in the development and manufacturing of biopharmaceuticals for third parties, and Instituto de Biologia Molecular do Paraná (“IBMP”), a Scientific and Technological Institution (ICT) and a supplier of quality products to the Brazilian health network, are proud to announce a strategic cooperation agreement to develop a biosimilar.

Under the agreement, Mabion will be responsible for the full development of a stable and robust bioprocess; next, scaling it up to a commercial manufacturing scale and followed by transferring the process to GMP conditions. Mabion will manufacture GMP drug substance for IBMP to support their clinical trials.

This work represents an important step in enabling IBMP to secure a supply of biosimilar therapeutics for the Brazilian market. Development efforts will include close collaboration with Sartorius as Mabion’s strategic partner, specifically leveraging its core expertise in cell line development.

This cooperation agreement will also kickstart the recently signed partnership agreement between Mabion and Sartorius. Dr. Pedro Ribeiro Barbosa, CEO of IBMP, stated: “The biosimilar project is the first of its kind in our pipeline. Due to the complex nature of the molecule and its importance, we have made every effort to identify trustworthy partners for its execution. We strongly believe that the combined expertise of Mabion and Sartorius will enable us to achieve our goals seamlessly.”

Krzysztof Kaczmarczyk, CEO of Mabion, commented: “This contract exemplifies the consistent implementation of our strategy to become a leading player in the biologics CDMO industry. We are proud that our knowledge, experience, and flexibility have been positively evaluated by our client, who has entrusted us with the execution of this crucial project. We are confident this marks the beginning of a long-term and mutually rewarding partnership.” The total value of the first Statement of Work (SOW) will amount to approximately PLN 18.3 million. Payments, denominated in USD, will be made systematically over 14 months, with services scheduled to begin in the second quarter of 2025.

This cooperation aligns with Mabion’s strategy to strengthen its position as a leading Contract Development and Manufacturing Organization (CDMO). It also marks the formal commencement of Mabion’s collaboration with Sartorius as a strategic partner, enhancing the comprehensiveness of services offered.