WuXi Biologics Launches HEK 293 Stable Cell Line Platform WuXia293 Stable for Development and Manufacturing of Difficult-to-Express Molecules

Rhea-AI Summary

WuXi Biologics (WXXWY) has launched WuXia293Stable, an innovative HEK293 cell line platform designed for developing and manufacturing difficult-to-express molecules. The platform achieves fed-batch titers up to 5.0 g/L for monoclonal antibodies while significantly improving purity.

The new platform demonstrates high titers, human glycosylation, and improved product quality by reducing truncation issues common in complex modalities. WuXia293Stable maintains stable expression during long-term cell passages and offers scalable manufacturing capabilities at 2000L scale for fed-batch and 1000L scale for perfusion.

This addition strengthens WuXi Biologics' WuXia™ platform family, which includes other specialized platforms like WuXiaADCC Plus™ and WuXia RidGS™, enhancing the company's comprehensive biologics development capabilities.

Positive

• Achieves high fed-batch titer of up to 5.0 g/L for monoclonal antibodies
• Platform eliminates or significantly reduces truncation issues in complex molecules
• Offers scalable manufacturing capabilities up to 2000L for fed-batch and 1000L for perfusion
• Maintains stable expression and consistent product quality during long-term cell passages

Negative

• None.

News Market Reaction

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• 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.

SHANGHAI, Aug. 11, 2025 /PRNewswire/ -- WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today 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^Stable offers 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. "

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 family include WuXia^ADCC Plus™ for developing and manufacturing afucosylated antibodies to elicit an enhanced ADCC response, WuXia RidGS™ for non-antibiotic cell line development, and the latest 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.

FAQ

What is WuXi Biologics' new WuXia293Stable platform and what does it do?

WuXia293Stable is a HEK293 cell line platform designed for developing and manufacturing difficult-to-express molecules, achieving high titers up to 5.0 g/L for monoclonal antibodies while improving product quality.

How does WuXia293Stable compare to traditional CHO cell expression systems?

Unlike CHO cells that may face low titer and truncation issues with complex modalities, WuXia293Stable can eliminate or significantly reduce truncation issues while maintaining high titer levels and providing human glycosylation.

What manufacturing scale can WuXi Biologics' WuXia293Stable platform achieve?

The platform enables scalable manufacturing at 2000L scale for fed-batch and 1000L scale for perfusion, maintaining stable expression and consistent quality during long-term cell passages.

What services does WuXi Biologics offer with the WuXia293Stable platform?

WuXi Biologics offers a comprehensive suite of services including cell bank testing and viral clearance validation as part of its one-stop CMC solution.

What are the key advantages of WXXWY's WuXia293Stable platform for biologics development?

Key advantages include high titers up to 5.0 g/L, improved product purity, reduced truncation issues, stable expression during cell passages, and flexible scalability for various development stages.