WuXi STA Opens new Parenteral Formulation Line

02.12.2022 - WuXi STA has started up a new parenteral formulation line at its drug product site in Wuxi City, China. The company’s second line for parenteral drug product clinical and commercial manufacturing to go on stream this year has an annual capacity of 10 million units.

The Chinese CDMO, a subsidiary of Wuxi AppTech, said the expansion in Jiangsu province demonstrates its continuous commitment to enhance its injectable drug product platform.

Wuxi STA’s 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.

According to the company, the filling speed can reach 200 vials per minute, significantly accelerating the production speed of large-volume parental drug products. The plant has a 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.

The production site preapproved by the European Medicines Agency (EMA), along with China’s National Medical Products Administration (NMPA), has an integrated drug product R&D and manufacturing campus with the comprehensive analytical platform for both oral and injectable formulations.

The CDMO said the site’s injectables platform supports all synthetic modalities including small molecules, oligonucleotides, peptides and complex conjugates. With the advanced sterile lipid nanoparticle (LNP) facility the company sees itself as well positioned to provide formulation development and manufacturing for oligonucleotides and the conjugates.

Looking ahead, the Chinese company said it plans to open a high potency (HP) parenteral formulation manufacturing line at Wuxi City in Q3 2023 to continue building up its activities in the field. In addition, injectable formulation development and manufacturing services will be available from its new US site at Middletown, Delaware, in 2025.

Author: Dede Williams, Freelance Journalist