Advancements in biopharmaceutical technology have broadened the application of large biologics in clinical settings, such as antibody drugs or protein drugs, produced using mammalian cells. The biological activity of these cells, however, poses a risk of variation during cultivation, potentially impacting drug quality. Hence, the development of stable cell lines has emerged as a crucial phase in ensuring the consistency and efficacy of pharmaceutical products while significantly cutting down on labor and time expenses.


In a pioneering collaboration, Leadgene Biomedical has joined forces with BICO Group's CYTENA in Germany and CYTENA Bioprocess Solutions (CYTENA BPS) to create a cutting-edge, competitive Cell Line Development (CLD) platform. This partnership aims to enhance the precision and technological advancement of cell cultivation through real-time monitoring with automated equipment.


Cheng-Han Tsai, CEO of CYTENA BPS, notes that despite the smaller scale of Taiwan's pharmaceutical or CDMO market, it is progressively moving toward full automation with governmental backing. At present, the United States and Europe are the only regions equipped with automated cell line development technology. By embracing such collaboration, Leadgene Biomedical positions itself as the first in Asia to offer an automated, high-throughput CLD platform, marking a significant milestone. The company further intends to globalize its reach, integrating biopharmaceutical advancements with automated processes.


Yung-Chun Chuang, Chairman of Leadgene Biomedical, celebrates the breakthrough in cell line platform and facility development, which has expanded the sector's technological prowess. Traditional manual monitoring methods fall short of providing comprehensive, immediate control. Through the adoption of automated equipment, the company can now monitor cell cultures in real-time, ensuring the provision of stable cell lines to downstream pharmaceutical producers and expediting the drug manufacturing process.


A standout feature of this technology includes a patented suspension culture technique that maintains cells in a suspended state within the culture medium, thereby stabilizing growth and maximizing yield. Leveraging in-house developed reagents and procedures, coupled with automation and integration technologies, significantly boosts cell culture efficiency and stability. Moreover, the automated platform minimizes human errors, hastens development timelines, and enhances overall efficiency, thereby reducing both development and production costs.


Through continuous refinement and optimization of culture processes designed for specific cell lines, Leadgene Biomedical, CYTENA BPS, and CYTENA enhance both the productivity and quality of particular cell strains. Moreover, they adeptly adjust to the diverse requirements of large biologics. This innovative integration exemplifies remarkable flexibility and adaptability. Through collaboration, Leadgene Biomedical and its partners are raising the bar for technical excellence in the biopharmaceutical industry, thereby establishing a robust foundation for extensive clinical applications in the years to come.