Mycenax Biotech, Inc. (4726.TWO) recently announced a strategic  cooperation with Sartorius to enhance CDMO capacity in Asia. Mycenax has introduced the cutting-edge 4Cell® CHO cell line development platform developed by Sartorius, a world leader in advanced manufacturing processes. Combined with AI-driven high-throughput screening technology, the platform can be used to establish a complete research cell bank (RCB) in 9 weeks. This partnership serves to demonstrate the strengths of resource integration and synergy by both Sartorius and Mycenax. How do they intend to optimize their end-to-end services, create brand differentiation, and become the most reliable CDMO partner for their clients? 

Sartorius’s cutting-edge 4Cell® CHO cell line development platform has a 9-week DNA-to-RCB timeline, which has enabled the approval and commercial manufacturing of seven biologics 

“As the leading one-stop CDMO for biologics, it is essential for Mycenax to provide a comprehensive platform connecting cell line construction to GMP manufacturing,” stated Mycenax Chair and CEO Pei-Jiun Chen.

Mycenax has extensive experience in the amplification and culture of cell lines for a range of CHO cell systems. By entering partnership with Sartorius to integrate its high-performing CHO cell line platform, Mycenax aims to expand the depth and breadth of its CHO cell line technology.

According to Mr. Chen, cell lines are essential to the entire production chain in biologics manufacturing, and difficulties regarding the culture of cells or insufficient production can adversely affect both drug quality and patient health.

The Sartorius cell line development platform is particularly suited to multi-specific antibody biologics and complex recombinant proteins, which require a high-performing host cell line and optimized expression vector to ensure robust cell line stability and high yields. In conjunction with Mycenax's process development capabilities and production scale experience, this partnership will provide customers with more efficient, affordable, and globally competitive biologic preparation options.

Sartorius Asia (excl. China) Bioprocess Solutions Head of Sales Tony Budianto Bee further explains that the Sartorius 4Cell® CHO cell line development platform incorporates an AI-driven high-yield cell line prediction and screening platform based on SIMCA that can be used to identify high-producer clones during the early stages of culture, thereby enhancing overall production efficiency.

Mr. Budianto Bee states that the 4Cell® CHO platform enables customers to develop stable cell lines from DNA to RCB in 9 weeks, and it is anticipated that the CDMO partnership with Mycenax will contribute to further shortening the DNA-to-clinic timeline.

Mr. Budianto Bee adds that the Sartorius 4Cell® CHO cell line platform is suitable not only for the development of monoclonal antibodies (mAb) but also for the design of complex proteins such as bispecific antibodies and fusion proteins, and to date the platform has successfully supported the commercial launch of seven biologics and biosimilars worldwide.

Building end-to-end, upstream, and downstream integrated solutions for biologics

Mr. Budianto Bee further emphasizes that whereas the Mycenax partnership focuses on upstream cell line development and culture technologies, optimization of downstream manufacturing processes is also essential for fully enhancing CDMO manufacturing efficiency.

Sartorius is actively driving innovation in downstream processing to keep pace with the increased productivity of upstream operations. In collaboration with industry partners, the company has developed advanced strategies such as Multi Column Chromatography (MCC), Rapid Cycling Chromatography (RCC), and connected multi-step chromatography (MS-MCC) to enhance purification efficiency. Their latest breakthrough, the Pionic® platform, is designed to intensify downstream processes. This modular system is adaptable to both new and existing facilities, starting with Pionic® Spin—a plug flow reactor virus inactivation skid that delivers consistent, regulatory-compliant performance across different production scales.

In response to market demands fueled by continuous bioprocessing bottlenecks, Sartorius is committed to the development of culture media and cell platforms suitable for upstream perfusion operating modes, with further opportunities to collaborate with Mycenax in order to promote improvements in the CDMO industry in the Asia–Pacific region.

Mycenax’s commitment to CDMO and continued development of world-class technologies

According to Mr. Chen, Mycenax has continued to develop the biologics CDMO market in Japan, Korea, and Taiwan under a brand position of “big D (development) and medium M (manufacturing)” and is committed to providing one-stop solutions for the biologics industry. Notably, Mycenax is the only company in Taiwan that provides 100% CDMO services for products other than its own, and is one of only a few companies that can seamlessly transition from upstream cell line culture to drug substance (DS) and sterile drug product (DP).

Mr. Chen believes that after obtaining the protein genetic engineering and cell line development technology from TPG Biologics, Inc. in 2019, Mycenax has significantly increased cell line development capacity and established a Manufacturing Science and Technology (MSAT) team that will contribute to accelerating the development of customer processes for biologics and introduction of a further range of advanced continuous manufacturing processes.

Currently, Mycenax has already implemented hundreds of CDMO projects, and in the past 6 months, the company has undergone regulatory inspections by agencies from different regions worldwide, including the Europe and Canada, and will begin to market supply pharmaceutical products to multiple regions in 2025. In the future, Mycenax also aims to collaborate with Sartorius to expand further into international markets, including Europe and the United States.

Sartorius Asia (excl. China) Head of Sales Development Julius Ang also mentions that this collaboration is not only a short-term cooperation but a commitment to a long-term partnership and will contribute to promoting more innovative biologics and sustainable manufacturing technologies, particularly given the current highly competitive market.