Lonza to establish drug product manufacturing capacity at Chinese facility
It will support the filling of liquid and lyophilized products.
The installation is expected to be completed in 2022; the contract development and manufacturing organization (CDMO) said the investment would create more than 150 new positions at the Guangzhou site.
The move sees drug product (DP) manufacturing capacity being established for clinical trial and commercial supply in China, added the Swiss group.
Jeff Li, vice president of commercial development, Lonza, told BioPharma-Reporter:
“The installation of the DP manufacturing line marks a significant milestone towards our long-term goal of increasing drug product capacity, both locally and globally. Most domestic projects need drug product manufacturing, as this is driven by local regulations.
“Regarding local DP demand, we see booming market needs, which are driven by commercial drugs launching in China in the future.”
He said the new line will serve clinical projects at small and mid-size DP batch sizes.
“More than 800 innovative molecules are currently under development in China; most of this pipeline represents mAbs that need DP services. Sophisticated know-how is needed to produce robust processes for these complex molecules,” continued Li.
The introduction of drug product manufacturing at that 17,000 m2 cGMP mammalian facility will be supported by the expansion of the company’s formulation and process development in Switzerland; Lonza is set to increase the footprint of its global drug product services hub in Basel.
The Guangzhou facility only began operations in Q2 2021; Lonza expects it to deliver its first cGMP batch later this year.
“The site is able to support both local customers in China as well as our global customers,” confirmed Li.