Shanghai, China, July 17, 2023 — WuXi STA, a global Contract Research, Development, and Manufacturing Organization (CRDMO), today launched its first high potency (HP), fully automated sterile injectable manufacturing line at the 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. This expansion allows the company to adeptly respond to the increasing demand of the high potency pharmaceuticals market.
Meeting Occupational Exposure Limits (OEL) as low as 10 ng/m3, the new HP injectable manufacturing line utilizes fully enclosed isolation systems and automated filling machines. This design effectively 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. Adhering to the International Society for Pharmaceutical Engineering (ISPE) guidelines, regular industrial hygiene monitoring is conducted to maintain the rigorous integrity of the sealed isolators. This commitment to stringent compliance, along with the integration of an independent air conditioning system and a bag-in bag-out (BIBO) exhaust air purification system, guarantees the safety of operators, the environment, and the product quality.
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, respectively. 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 also set to be added to the Couvet site in Neuchâtel, Switzerland and upcoming Middletown site in Delaware, USA.
The ongoing enhancement of the injectable platform will also effectively synergize with the WuXi TIDES CRDMO platform, providing integrated CMC solutions for both API and drug products for the development of oligonucleotides, peptides, and related complex chemical conjugates. To date, WuXi TIDES has gained experience from over 30 integrated CMC projects related to oligonucleotide and peptide drugs. The completed projects have demonstrated notable speed and efficiency advantages, typically progressing from API process development to being IND-ready within a 9-10 month timeframe.
In addition, WuXi STA has established comprehensive capabilities in R&D and production of HPAPI with many years of experience. With the launch of the new HP injectable line, combined with the HP oral drug production line, the company further enhanced its HP CMC platform that now provides an end-to-end solution including both API and drug product, seamlessly covering the entire life cycle of HP new drug development from research all the way to commercial manufacturing.
“I’m thrilled that our HP injectable R&D and manufacturing platform has achieved yet another significant milestone,” said Dr. Minzhang Chen, 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.”
About WuXi STA
WuXi STA (stapharma.com), a subsidiary of WuXi AppTec (wuxiapptec.com), is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry, with global operations. As a premier contract development and manufacturing organization (CRDMO), WuXi STA offers its worldwide partners efficient, flexible and high-quality solutions for integrated chemical, manufacturing and controls (CMC) from preclinical to commercial uses, including the development and manufacturing of small molecule, oligonucleotide, peptide and various complex chemical conjugate.
For more information, please visit: https://sta.wuxiapptec.com/
