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WuXi STA’s new high-potency injectable line has an annual capacity of 12 million units.
WuXi STA, a contract research development and manufacturing organization (CRDMO) that functions as a subsidiary of WuXi AppTech, announced the launch of its first high potency (HP) fully automated sterile injectable manufacturing line at its drug product site in Wuxi City, China on July 17, 2023. According to a company press release, the new HP injectable line has an annual capacity of 12 million units, and will enhance the company’s manufacturing capabilities and capacity for injectable dosage forms.
The line uses fully enclosed isolation systems and automated filling machines, which is intended to minimize human intervention, prevent cross-contamination, and ensure quality assurance for sterile products; according to the release, the new line meets Occupational Exposure Limits as low as 10 nanograms per cubic meter. Additionally, the line is equipped with two 20 meters squared lyophilizers with a filling rate of up to 200 units per minute, which are designed to support liquid and lyophilized vials of various specifications.
"I'm thrilled that our HP injectable R&D and manufacturing platform has achieved yet another significant milestone," said Minzhang Chen, co-CEO, WuXi AppTec, and CEO, WuXi STA, in the release. "In addressing the growing needs of high potency drugs, WuXi STA... will continue to strengthen our CRDMO platform capabilities. With our proven track record of consistent quality and [environment, health, and safety] systems across all sites globally, we are committed to accelerating pharmaceutical development and bringing new therapeutics for patients worldwide."
According to the release, WuXi STA plans to add two more injectable manufacturing lines at the same site by 2024. In that timeframe, additional lines are also set to be added to the Couvet site in Neuchâtel, Switzerland and the upcoming Middletown site in Delaware, USA.
Source: WuXi STA