CDMO WuXi Biologics installed Cytiva’s SA25 aseptic filling workcell at its DP4 drug product operations, reaching its first good manufacturing practice (GMP) batch release 15 months after purchasing the machine in 2018. As of April 2020, WuXi Biologics is filling vials, syringes and cartridges for clients at clinical and commercial levels with a quality acceptance rate of up to 99.5% of units produced. The company announced a ‘scale out’ expansion using 5 additional SA25 aseptic filling workcells.
DP4 has successfully completed 13 batches of drug product filling and passed 6 audits with no critical findings. Inspectors included former U.S. FDA officers and EU Qualified Persons. The company has booked 50 future filling projects on the SA25 at DP4.
“Featuring modularization, robotic automation, and a closed system, this state-of-the-art line reflects our leadership in biologics manufacturing innovation. DP4 has demonstrated our diverse aseptic filling capabilities, maintaining high product quality and extensive flexibility to serve the complex biologics filling needs of our clients.”
– Dr. Chris Chen, CEO, WuXi Biologics
Matching technology with customer needs
WuXi Biologics chose Cytiva’s SA25 aseptic filling workcell to act as a flexible filler for clinical and small-volume commercial drug products being filled into vials, syringes, and cartridges. The selection team’s goals were flexibility, quality assurance, and technology transfer:
- Fill vials, syringes, and cartridges with short decontamination cycles
- Designed for maximizing yields and reducing rejection rates
- Accelerated technology transfer with a standard machine, where new products / recipes can be added quickly
Project timeline
April 2018 – WuXi Biologics buys the SA25 aseptic filling workcell
CDMO WuXi Biologics buys the SA25 to offer vial, syringe, and cartridge dosages to its clients.
June 2018 – Detailed facility design and project kick-off
The project is kicked off between the 2 companies and the detailed design work of the SA25’s installation is completed.
November 2018 – Factory acceptance test (FAT) completed
The WuXi Biologics team completes the factory acceptance test working with our technical services team in Vancouver.
December 2018 – Site acceptance test completed
The SA25 is shipped from Vancouver to Wuxi, China, where it is installed, and the site acceptance test is completed – all in 1 month.
March 2019 – Qualification and VHP cycle development completed
The WuXi Biologics team completes the SA25’s commission, installation qualification, operational qualification, and performance qualification, as well as the vapour-phase hydrogen peroxide (VHP) decontamination cycle development.
June 2019 – Media fills completed
The WuXi Biologics team completes media fills into pre-filled syringes and vials.
July 2019 – First GMP batch release
The first GMP batch release of client drug products is achieved, 15 months after the purchase order for the SA25 aseptic filling workcell.
What did the project team achieve?
| Area | Achievement |
|---|---|
| Flexibility | By the time of GMP release, the SA25 was validated for 1 mL long syringes, 1-3 mL syringes, 5 mL syringes, 10 mL syringes, and 2R, 4R, 6R, 8R, 10R, 15R, 20R, 25R, 30R and 50R vials. Typical decontamination times range from 25-40 minutes, including aeration. |
| Quality assurance | Up to 99.5% acceptance rate of units produced. |
| Technology transfer | 50 filling projects booked on the machine as of April 2020. Additional SA25 units planned for scale out expansion. |
WuXi Biologics’ success with their first SA25 aseptic filling workcell will be expanded with their recent purchase of several more machines. As standard systems, these additional workcells can be built and validated quickly. Once ready, recipes from one machine can be transferred to the others to scale out production.
“WuXi Biologics will continue to invest in cutting-edge technologies to fulfill our mission, enabling global partners to advance product approvals for the benefits of patients worldwide.”
– Dr. Chris Chen, CEO, WuXi Biologics