WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), has unveiled TrueSite TI™, a next-generation CHO cell line platform built on targeted integration technology. Designed to transform biologics development, this innovation accelerates development timelines, enhances product quality, and ensures consistent scalability for antibody-based and complex protein therapies.
Targeted integration offers a precision approach to cellular engineering by directing expression units into predefined and thoroughly validated locations within host cells. Unlike conventional random integration or transposase-based methods, this technique dramatically streamlines development by narrowing clone screening to a small number of candidates, improving long-term expression stability, and enabling significantly faster Investigational New Drug (IND) submissions.
TrueSite TI™ represents the fourth evolution of WuXi Biologics’ proprietary WuXia™ platform, a proven system that has supported more than 1,000 molecules over the last decade. With its latest advancements, the platform achieves an average monoclonal antibody (mAb) titer of more than 8.0 g/L, enabling high-yield commercial production. It also ensures greater consistency across pools and clones, with over 99% of clonal cell lines maintaining stable protein expression after 60 generations. This minimizes risks of titer decline during scale-up manufacturing processes, which can extend to volumes exceeding 20,000 liters.
Although optimized for monoclonal antibodies, TrueSite TI™ has also demonstrated robust performance in developing complex biologics such as bispecific antibodies (BsAbs), Fc-fusion proteins, and Fab fragments. The platform provides exceptional stability, a predictable growth profile, and seamless consistency from pool to clone, while streamlining workflows to reduce timelines. Importantly, TrueSite TI™ supports a best-in-class 6-month IND submission, accelerating the pathway to clinical trials for novel therapeutics.
Commenting on the launch, Dr. Chris Chen, CEO of WuXi Biologics, emphasized the critical role of cell line development in advancing new therapies. He noted that TrueSite TI™ delivers breakthroughs in both efficiency and quality, empowering clients to accelerate innovative research and development. By combining cutting-edge technologies with a comprehensive suite of CRDMO services, WuXi Biologics aims to help biopharma companies deliver transformative therapies faster and improve outcomes for patients worldwide.
