• WuXia293^Stable platform demonstrates high titer, human glycosylation and improved product quality by eliminating or significantly alleviating truncation in difficult-to-express molecules.
• WuXia293^Stable platform maintains stable expression and consistent product quality during long-term cell passages, enabling scalable clinical and commercial manufacturing.

WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO),  announced the launch of WuXia293^Stable, a new platform designed for the development and manufacturing of innovative, difficult-to-express molecules that are stably expressed in HEK293 cells. The platform, which demonstrates high titers, robust stability and superior quality, significantly enhances the developability and manufacturability of these molecules, offering a highly efficient CMC solution for biologics that are sophisticated in both structure and function.

Conventionally, CHO cells have been widely utilized for recombinant protein expression with proven track record of high titers, and good developability and manufacturability. However, complex modalities may not be compatible with CHO expression system, resulting in low titer levels and truncation issues, due to the impact of some CHO-specific host cell proteins (HCPs), that compromise the quality and functionality of the protein products. In contrast, HEK293 cells can eliminate or significantly alleviate truncation issues in expressing complex molecules while maintaining high titer levels.

WuXi Biologics developed WuXia293^Stable by leveraging its proprietary HEK293 cell line. Derived from WuXi Biologics' highly-vetted mammalian cell line development platform family WuXia™, WuXia293^Stable demonstrates productivity, quality and stability comparable to WuXia™ while maintaining full compatibility with its process, as shown by its robust growth and balanced metabolism.

The platform achieves a fed-batch titer of up to 5.0 g/L for monoclonal antibodies while significantly improving purity. WuXia293^Stableoffers flexible scalability in culture scale to meet the diverse needs of various research and pre-clinical development stages. Furthermore, the WuXia293^Stable cell line maintains stable expression and consistent quality during long-term cell passages, enabling scalable clinical and commercial manufacturing at 2000L scale for fed-batch and 1000L scale for perfusion. Moreover, WuXi Biologics offers a comprehensive suite of services for the WuXia293^Stable platform, including cell bank testing and viral clearance validation as part of its one-stop CMC solution.

The launch of the WuXia293^Stable platform has further strengthened the service capabilities of WuXi Biologics' WuXia™ platform family. Besides WuXia293^stable, the WuXia™ platform has already derived multiple cell line development platforms, including WuXia^ADCC Plus™ and WuXia RidGS™, to address customers' diverse requirements.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are excited to launch an industry-leading solution that significantly enhances the development of advanced therapeutics. WuXia293^Stable stands as a powerful testament to WuXi Biologics' unwavering commitment to our vision that every biologic can be made and exemplifies our dedication to technological innovation, which enables us to adeptly address the evolving needs of the biopharmaceutical industry. Once again we are reaffirming our promise to enable our clients in accelerating the delivery of innovative biologics to patients worldwide. "