66 TWENTYFOURSEVENBIOPHARMA Issue 1 / March 2025 MABION The biologics sector is growing rapidly, with the global monoclonal antibody market projected to reach $500 billion by 2030. However, biopharma companies face challenges such as manufacturing bottlenecks, supply chain disruptions, and increasing regulatory requirements. The U.S. biopharma market is experiencing unprecedented demand for high-quality, flexible, and scalable CDMO solutions. To address these issues, Mabion offers a fully integrated CDMO platform, providing customized manufacturing solutions tailored to the needs of the U.S. market. EU-based CDMO with deep expertise in biosimilars and recombinant proteins is uniquely positioned to support the growing needs of U.S. biopharmaceutical companies. Our transformation from a biosimilar developer to a full-service CDMO has equipped us with experience and infrastructure to provide solutions from process development to GMP manufacturing and wide physicochemical, structural and biological analytical panel. Our quality management system is aligned with FDA, EMA, and ICH standards, ensuring full regulatory compliance. We have honed our expertise in process validation, analytical characterization, and regulatory submissions, making us an ideal partner for U.S. biopharma companies seeking smooth FDA approval pathways. With our cutting-edge 2,000L and 2,500L single-use bioreactor systems, state-of-the-art downstream purification technologies, and inhouse analytics, we offer seamless technology transfer, rapid process development, and highyield manufacturing solutions. Our flexible approach allows us to work with both startups and established biopharma companies in the U.S. looking for cost-efficient, high-quality production partners. At the core of our U.S. expansion strategy is our collaboration with Novavax, where Mabion plays a pivotal role in producing the SARSCoV-2 recombinant spike protein for Novavax’s COVID-19 vaccine. As the pandemic unfolded, the demand for quality vaccine manufacturing skyrocketed, putting immense pressure on the global supply chain.
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