WuXi opens continuous manufacturing line for oral solids

WuXi STA, a subsidiary of WuXi AppTec, opened the new continuous manufacturing line and confirmed that it had already begun operations. The line is located within the company’s formulation development and manufacturing campus in Wuxi City.

The continuous manufacturing line features continuous direct compression equipment with unit operations including dispensing, blending, lubrication, tablet compression, and coating.

WuXi STA states that the process analytical technology (PAT) is implemented within the continuous manufacturing line to monitor blending uniformity. The technology utilized also allows for real-time analysis and control during production to monitor product quality.

The contract development and manufacturing organization (CDMO) outlined that adding the continuous manufacturing line should enable higher yields to be achieved and to ensure shorter timelines to market for clients developing oral drug solutions.

The move by WuXi STA comes as there is a general push in the direction towards greater adoption of continuous technology across the industry, both from the larger CDMOs and from regulators​. This move is being promoted by multiple factors​: the flexibility of the approach, the ability to reduce costs, and potential improvements to efficiency.

For WuXi STA, the decision to add the continuous manufacturing line comes amid a broader push to build out its operations in oral solid dosage forms.

In December 2022​, the company announced that it had completed adding a parenteral formulation manufacturing line for oral solid dosage forms to its drug product site in Wuxi City. This addition represented the second time during the same year that WuXi STA had expanded the number of manufacturing lines at the facility.

At a different location, in Changzhou, China, the company also opened a high-potency active pharmaceutical ingredient (HPAPI) plant. At the time​, Youchu Wang, head of early stage development at WuXi STA, told Outsourcing-Pharma, “Specific to HPAPI capability and capacity, our expansion won’t stop at this new plant in Changzhou. We announced our new 170-acre Taixing site in Jiangsu China last year. We will build more HPAPI plants in Taixing in the next few years.”​

Wider than HPAPIs, Wang confirmed that the company is ‘continuously expanding’ capabilities in small molecule drug manufacturing and new treatment modalities, including oligonucleotides, peptides, and their conjugates.

As such, the company will open a new high potency parenteral manufacturing line in the third quarter of 2023, located in the Wuxi City campus.