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WuXi STA Debuts First HP Sterile Injectable Mfg. Line at Wuxi Site

Annual capacity of 12 million units enhances manufacturing capabilities and capacity for injectable dosage forms.

By: Kristin Brooks

Managing Editor, Contract Pharma

WuXi STA launched its first high potency (HP), 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, enhances manufacturing capabilities and capacity for injectable dosage forms.
 
The new line meets Occupational Exposure Limits (OEL) as low as 10 ng/m3 and utilizes fully enclosed isolation systems and automated filling machines. This design minimizes 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 two 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 (LNP) 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, USA. 

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