WuXi STA launched a high potency, fully-automated sterile injectable manufacturing line at its drug product site in Wuxi City, China. The new line has an annual capacity of 12 million units and meets Occupational Exposure Limits as low as 10 ng/m3 and utilizes fully enclosed isolation systems and automated filling machines, according to a company official.
The design reportedly minimizes human intervention, preventing cross-contamination and ensuring quality assurance for sterile products. The line is equipped with two 20 m2 lyophilizers and supports liquid and lyophilized vials of various specifications, with a filling rate of up to 200 units per minute.
Two fully-automated sterile injectable manufacturing lines
The Wuxi City drug product site currently has two fully-automated sterile injectable manufacturing lines, with manufacturing capacity of 2 million and 10 million units annually. These lines support various dosage forms, including liquid and lyophilized vials, pre-filled syringes, and cartridges.
In addition, the company’s sterile lipid nanoparticle platform has also started operation at the Wuxi City site, with a batch production capacity ranging from 10 to 50 liters, supporting the formulation development of complex new modalities, especially oligonucleotide-based drug candidates.
By 2024, WuXi STA plans to add two more injectable manufacturing lines at the same site, with additional lines to be added in Couvet, Switzerland, and at the upcoming Middletown site in Delaware.
“I’m thrilled that our HP injectable R&D and manufacturing platform has achieved yet another significant milestone,” said Minzhang Chen, PhD, Co-CEO of WuXi AppTec and CEO of WuXi STA. “In addressing the growing needs of high potency drugs, WuXi STA, as an innovation enabler, will continue to strengthen our CRDMO platform capabilities. With our proven track record of consistent quality and EHS systems across all sites globally, we are committed to accelerating pharmaceutical development and bringing new therapeutics for patients worldwide.”