WuXi Biologics Launches WuXia™4.0, Targeted Integration Cell Line Platform TrueSite TI™，to Accelerate Biologics Development with High Titer and Superior Stability

• TrueSite TI™, the fourth generation of WuXia™ cell line platform, leverages targeted integration technique to streamline clone screening and guarantees expression stability.
• The platform has achieved an average mAb titer exceeding 8.0 g/L with over 99% of clonal cell lines maintaining stable protein expression after passaging for 60 generations, which effectively mitigates the risk of titer drop during scale-up manufacturing to over 20,000 L.
•  It enables a 6-month IND timeline, accelerating development of innovative therapies and their path to commercial launch.
• TrueSite TI™ has proved to be ideal for mAb development and demonstrated strong applicability to complex biologics, including bispecific antibodies (BsAb), Fc-fusion proteins, and Fab fragments.

SHANGHAI, Sept. 25, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the launch of TrueSite TI™, an industry-leading targeted integration (TI)-based CHO cell line platform designed to reshape biologics development by accelerating timelines, enhancing product quality, and ensuring consistent scalability for antibody and complex protein therapies.

Targeted integration is a precision-driven cellular engineering technique that enables the delivery of target expression units to predefined and rigorously validated locations in the host cells. Unlike conventional random integration or transposase methods, it streamlines development by limiting clone screening to just dozens of candidates, ensuring long-term expression stability, and significantly shortening IND timelines.

TrueSite TI™ is the fourth generation of WuXi Biologics' proprietary WuXia™ cell line platform, an established system for generating high-titer, stable cell lines that has been technologically evolved and validated in over 1000 molecules over the past decade. TrueSite TI™ drives greater efficiency and quality with cutting-edge innovations. It has achieved an average monoclonal antibody (mAb) titer exceeding 8.0 g/L, supporting high-yield commercial manufacturing. It also significantly improves pool and clone quality consistency. Over 99% of the platform's clonal cell lines have maintained stable protein stability after passaging for 60 generations, mitigating the risk of titer drop during scale-up manufacturing to over 20,000 L. 

While TrueSite TI™ has proved to be ideal for mAb development, it has also demonstrated strong applicability to complex biologics, including bispecific antibodies (BsAb), Fc-fusion proteins, and Fab fragments, delivering outstanding cell line stability, a reliable and predictable growth profile, and seamlessly consistent pool-to-clone quality. By streamlining process development workflows, TrueSite TI™ provides clients with an industry-leading 6-month IND timeline, enabling fast clinical trials for breakthrough therapeutics.

Dr. Chris Chen, CEO of WuXi Biologics, commented: "With biopharmaceutical companies striving to bring high-quality, life-saving therapies to patients faster, cell line development stands as the critical point in achieving this mission. WuXi Biologics continues to advance its WuXia™ platform, pushing the boundaries of cell line development. As the fourth generation of the platform, TrueSite TI™ has achieved dual breakthroughs in both 'quality' and 'efficiency' of cell lines, enabling our clients to lead the forefront of innovative therapeutics R&D. As a CRDMO partner, we are fully equipped with both cutting-edge technologies and a comprehensive suite of services to address the diverse needs of our clients, enabling them to succeed in the rapidly evolving era of biologics and ultimately to benefit patients worldwide."

About the WuXia™ Cell Line Development Platform Family

 WuXia™ is a proven, high-yield (up to about 11 g/L) mammalian cell line platform family developed by WuXi Biologics. Accepted by regulatory agencies worldwide, the WuXia™ platform family have generated over 1000 cell lines expressing monoclonal and bispecific antibodies, fusion proteins, enzymes and other recombinant proteins for clinical and commercial manufacturing as of 2024. The WuXia™ platform has seen continuous technical advancements, and TrueSite TI™ is its fourth-generation version. It leverages industry-leading targeted integration technology to significantly enhance cell line titer and stability, greatly boost cell line development efficiency, and ultimately enable faster biologics development.

The WuXia™ platform family also include WuXia^ADCC Plus™ for developing and manufacturing afucosylated antibodies to elicit an enhanced ADCC response, WuXia RidGS™ for non-antibiotic cell line development, WuXia293 ^{Stable ™} for expressing difficult-to-express molecules built on HEK293 cell lines. The WuXia™ cell line development platform family continue to expand to cater to the diverse needs of global customers.

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SOURCE WuXi Biologics