Construction begins on new WuXi microbial manufacturing site

WuXi Biologics has announced that construction of its new 95,000m² microbial manufacturing site in the Wenjiang district of Chengdu, China, has begun.

With both a drug substance and a drug product facilities, the site will enable commercial production for multiple modalities, including peptides, antibody fragments, plasmid DNA and virus-like particles (VLPs).

Facilitating advanced microbial manufacturing 

The facilities will feature WuXi Biologics’ new microbial expression platform for production of biologics with “high yield, consistent quality, and superior stability and scalability, achieving titres that exceed 15 g/L for non-mAb recombinant proteins”, the company explained.

Notably, the microbial manufacturing facility will house China’s first dual-chamber lyophilisation production line alongside a vial filling line. Overall drug product manufacturing capacity exceeds 10 million vials annually, the company reported.

The site in Chengdu will be equipped with a 15,000L fermenter, enabling an annual production capacity of 80 to 110 drug substance batches. In the long-term, the fermenter has expansion potential up to 60,000L. Additionally, the facilities will use advanced automated systems to support regulatory compliance, operational efficiency, and high-quality products.

The new manufacturing site will include capabilities and processes aimed at minimising its environmental footprint while maintaining high production standards. Specifically, this involves optimising process development approaches and utilising carbon tracking mechanisms.

WuXi Biologics highlighted that facility will be used to produce a long-acting growth hormone for paediatric growth hormone deficiency (PGHD). This supports the company’s drive to meet the growing demand for advanced biologics. 

“With the booming global market for microbial products presenting unprecedented potential for next-generation therapies, our Chengdu site — with its robust production scale and cutting-edge technologies — is ideally positioned to capitalise on this trend,” Dr Chris Chen, CEO of WuXi Biologics commented.

The new microbial manufacturing site is scheduled to complete GMP release for production by the end of next year.