WuXi STA has announced that its first parenteral formulation manufacturing line at the Wuxi city site is now in commission. This wholly automatic sterile manufacturing line operates in a full isolation system with an annual capacity of two million units, a company statement said.
It also said that the automatic parenteral filling line features multiple filling modules and a built-in lyophiliser to fill vials, syringes and cartridges of a full range of sizes, as well as to produce lyophilised powders. Different filling modules can be switched rapidly, allowing for maximum flexibility and production efficiency.
The statement further mentioned that this new parenteral formulation manufacturing line and the sterile manufacturing plant at Wuxi city site are designed per cGMP requirements by US FDA, EMA and China NMPA, equipped with the industry’s latest generation of isolation system and filling machine. The entire filling process is performed by robotics in a full isolation system, designed to minimise human interventions and eliminate contaminations to ensure high product quality.
Further, according to the statement, WuXi STA’s drug product platform covers a full range of services including solid-state development, pre-formulation, formulation development and clinical-to-commercial drug product manufacturing for a broad range of oral and injectable dosage forms. In addition to the launch of this parenteral formulation manufacturing line, a second sterile filing line with an annual capacity of 10 million units is scheduled to start operation in Q3 this year at the same site.
With the addition of the sterile manufacturing line, WuXi STA’s new modality CRDMO platform provides an end-to-end solution for oligonucleotides, peptides as well as complex conjugates from API to drug product, from discovery to commercial manufacturing, the statement concluded.