21 July 2023 | News
For addressing the growing needs of high potency drugs
WuXi STA, a global Contract Research, Development, and Manufacturing Organisation (CRDMO), has launched a first high potency (HP), fully automated sterile injectable manufacturing line at its drug product site in Wuxi City, China.
The new HP injectable manufacturing line, with an annual capacity of 12 million units, further enhances the company’s manufacturing capabilities and capacity for injectable dosage forms – providing greater flexibility to respond to the increasing demand of the high potency pharmaceuticals market.
The injectable manufacturing line meets Occupational Exposure Limits (OEL) as low as 10 ng/m3 and utilises fully enclosed isolation systems and automated filling machines. This design minimises human intervention, preventing cross-contamination and ensuring stringent 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.
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.
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, USA.