WuXi Biologics has completed 2,000L of drug substance (DS) GMP manufacturing using its proprietary ultra-intensified fed-batch bioprocessing platform, WuXiUI.
WuXi Biologics is a global contract research, development, and manufacturing organisation (CRDMO).
WuXiUI platform achieved a titre of 18 g/L, marking a fourfold increase over traditional fed-batch processes, CRDMO claimed.
Additionally, the company’s advanced downstream technology platform has doubled purification processing capacity while maintaining similar impurity removal rates.
The advancement led to a 50% reduction in downstream processing time and a final drug substance (DS) yield of 70%, all while preserving product quality.
Furthermore, the WuXiUI downstream platform has achieved a 30-50% reduction in the use of materials and consumables, significantly minimising waste generation.
These improvements in overall DS production have markedly lowered the cost of goods sold (COGS) for manufacturing, resulting in a notable boost in economic efficiency for biologics production, the company said.
WuXi Biologics CEO Chris Chen said: “The successful application and achievement of WuXiUI is a result of our relentless pursuit of technology innovation to speed up biologics development while achieving cost efficiency for global clients.
“With this milestone, we have enhanced our capabilities to enable clients to bring more affordable, high-quality biologics to market, benefiting patients worldwide.”
Launched in 2023, the WuXiUI platform boosts productivity across various CHO and other mammalian cell lines that produce a range of product modalities.
The platform is designed to support global clients aiming to meet the increasing demand for therapeutic proteins and antibodies, all while reducing the COGS.
Additionally, WuXiUI supports a lower carbon footprint through efficient media usage, reduced waste generation, and decreased space requirements in production facilities.
WuXi Biologics said that the recent scale-up of the platform underscores the technology’s readiness for large-scale production.
WuXiUI’s performance was further enhanced using MagniCHO, WuXi Biologics’ proprietary cell culture media.
Additionally, the integration of the Raman Process Analytical Technology (PAT) tool into the scale-up manufacturing process improved operational efficiency and production robustness.
Last month, WuXi Biologics signed a three-year, multi-target strategic partnership with Medigene to design and co-research T cell receptor (TCR)-guided T Cell Engagers (TCR-TCEs) for the treatment of difficult-to-treat tumours.
