Renzoku Biologics Inc., today announced a collaboration with Auxilart Co., Ltd. to develop mathematical models aimed at accelerating biopharmaceutical manufacturing process development.
　　The partnership will combine Renzoku Biologics’ advanced biomanufacturing capabilities to support the development of an Advanced Biomanufacturing Factory with Auxilart’s modeling and simulation technology, integrating digital modeling into real-world process development.
Biopharmaceutical process development has become increasingly complex as product modalities evolve and quality requirements continue to rise. In particular, biological processes such as cell culture require extensive experimentation to manage biological variability and generate reliable data. CDMOs across the industry have accordingly been focusing on building rapid and reliable process development capabilities through the systematic accumulation of experimental knowledge and expertise.
　　By combining experimental work with mathematical modeling and simulation, the two companies aim to improve development efficiency, deepen process understanding, and reduce the number of experimental iterations required during development. Maximizing the value of experimentally derived insights through simulation to further enhance development efficiency has become a critical factor in strengthening competitive advantage going forward.
　　Under the collaboration, Auxilart will develop mathematical models and conduct simulation analyses, while Renzoku Biologics will perform experimental studies and generate process data within operational manufacturing environments. The joint effort will focus initially on modeling cell culture processes to enable more efficient exploration of operating conditions and improved process understanding.
Looking further ahead, both companies aim to extend this modeling technology beyond cell culture process development to encompass cell line screening and downstream processing, enabling more rapid progression from process design through scale-up. “Renzoku Biologics is committed to implementing advanced manufacturing technologies that enable the next generation of biopharmaceutical production,” said Kuboniwa Hitoshi, CEO of Renzoku Biologics. “By working with Auxilart, we expect to introduce model-driven approaches from the early stages of process development, enabling more efficient development and more flexible manufacturing. Going forward, we also aim to leverage this collaboration to strengthen our competitive positioning in the global market.
　　The collaboration reflects a broader shift within the pharmaceutical industry toward integrating digital technologies and modeling approaches into bioprocess development to accelerate innovation and improve manufacturing performance.”

　　Junu Kim, CEO of Auxilart, added: “This collaboration represents an important step toward implementing model-driven process development in biopharmaceutical manufacturing. Biopharmaceutical manufacturing has long been supported by the rich accumulation of experimental expertise and knowledge built up over many years. Through this collaboration, we aim to formalize and leverage that expertise in the form of structured mathematical models, improving development speed, reproducibility, and scalability. By uniting the strengths of both organizations, we look forward to advancing digitalization in biopharmaceutical manufacturing and contributing to the establishment of next-generation biomanufacturing infrastructure.”