#China #Shanghai #WuXi Biologics #TrueSite TI™ #WuXia Platform

WuXi Biologics Launches TrueSite TI™

In an impressive step forward for biopharmaceutical development, WuXi Biologics has announced the launch of TrueSite TI™, the latest iteration of its renowned WuXia™ cell line platform. Designed to expedite the biologics development process, this innovative platform utilizes targeted integration technology to facilitate clone screening while ensuring superior expression stability for therapeutic proteins.

The Advancements of TrueSite TI™

TrueSite TI™ marks the fourth generation of the WuXia™ platform, bringing significant improvements in the efficiency and quality of cell line development. It has been engineered to achieve an average monoclonal antibody (mAb) titer exceeding 8.0 g/L. This impressive yield not only supports the requirements of high-yield commercial manufacturing but also reduces operational risks associated with titer drop during scale-up procedures, even for large-scale production exceeding 20,000 liters.

Dr. Chris Chen, CEO of WuXi Biologics, stated, "In today's fast-paced biopharmaceutical environment, the need for high-quality therapies delivered swiftly to patients has never been more critical. TrueSite TI™ represents a pivotal breakthrough in achieving both efficiency and consistency in the development of cell lines, enabling our partners to remain competitive in the market."

Enhanced Stability and Scalability

The platform's efficiency is underscored by its ability to maintain stable protein expression in over 99% of clonal cell lines after passaging for 60 generations. This feature significantly mitigates the risks often associated with traditional development methods, where variations in yield and quality can hinder the progress of clinical trials. By limiting the number of candidates deemed viable for screening down to just a few dozen, TrueSite TI™ allows for a more streamlined and predictable development pathway, contrasting starkly with the conventional random integration methodologies.

Applicability Across Biologics

While primarily tailored for mAb development, TrueSite TI™ demonstrates extensive applicability across a range of complex biologics, including bispecific antibodies (BsAbs), Fc-fusion proteins, and Fab fragments. This versatility is vital as biotech firms increasingly pivot towards the development of multifaceted protein therapies that require impeccable stability and predictable growth profiles.

WuXi’s dedication to advancing the WuXia™ platform has been reflected in its utilization across over 1000 molecules in the last ten years, confirming its reliability and effectiveness within the industry. Furthermore, it has gained acceptance from regulatory bodies globally, solidifying its reputation as a go-to solution for both clinical and commercial manufacturing needs.

Closing Thoughts

With the introduction of TrueSite TI™, WuXi Biologics not only enhances its portfolio but also reinforces its commitment to support the biopharmaceutical sector in overcoming challenges associated with novel therapeutic development. By fostering environments for rapid clone generation and reliable scalability, WuXi aims to play a pivotal role in the next wave of innovative drug therapies that can significantly impact patient outcomes.

Overall, the launch of TrueSite TI™ signals a promising advancement in the intricate landscape of biologics, setting the stage for faster delivery of essential therapies to patients around the globe. As WuXi Biologics continues to push boundaries in biologics development, the industry can expect a future where high-quality therapies are more accessible, enhancing healthcare outcomes for an ever-growing patient population.