01 December 2022 | Thursday | News
This new line features a fully automatic vial loading/unloading system and a built-in 15 m2 lyophilizer in a fully enclosed isolator. The filling line supports vials in a full range of sizes for solutions and lyophilized powder while allowing rapid switches between modes for maximum filling flexibility and efficiency. The filling speed can reach 200 vials per minute, significantly accelerating large-volume parental drug product production speed. This facility is designed per global cGMP standards, equipped with state-of-the-art containment system and advanced filling machine. From vial cleaning, drying, filling to freeze-drying, the entire process is wholly automated in the isolator to ensure high product quality with minimal human interventions.
Located in Jiangsu, China, the Wuxi city site is an integrated drug product R&D and manufacturing campus with the comprehensive analytical platform for both oral and injectable formulations. The site has passed Pre-Approval Inspections from both European Medicines Agency (EMA) and China National Medical Products Administration (NMPA), sharing the same proven quality system across all sites within WuXi STA. The injectable platform at the site supports all synthetic modalities including small molecules, oligonucleotides, peptides and complex conjugates. With the advanced sterile lipid nanoparticle (LNP) facility at Wuxi city, the site is well positioned to provide formulation development and manufacturing for oligonucleotides and the conjugates.
To continue enhancing the injectable platform capabilities, a high potency (HP) parenteral formulation manufacturing line is slated to begin operations in Q3 2023 at Wuxi city site. In addition, injectable formulation development and manufacturing services will be available from the company’s new site at Middletown Delaware US in 2025, further enhancing the platform capability and capacity for global customers.
Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA, commented, "I am glad that our parenteral drug product capacity has been expanded to meet the growing demands. WuXi STA is committed to strengthening our integrated CMC platform and building first-in-class facilities with cutting-edge technologies. We strive to provide our global partners with flexible, fast, and cost-efficient solutions to accelerate new therapies to market for patients worldwide."