CDMO WuXi Biologics installed the Vanrx SA25 Aseptic Filling Workcell at its DP4 drug product operations, reaching its first 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 has just announced a ‘scale out’ expansion using five additional SA25 Aseptic Filling Workcells.
DP4 has successfully completed 13 batches of drug product filling and passed six 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.
Matching technology with customer needs
WuXi Biologics chose Vanrx’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.
- Apr. 2018
- June 2018
- Nov. 2018
- Dec. 2018
- Mar. 2019
- June 2019
- Jul. 2019
CDMO WuXi Biologics buys the SA25 to offer vial, syringe and cartridge dosages to its clients.
The project is kicked off between the two companies and the detailed design work of the SA25's installation is completed.
The WuXi Biologics team completes the Factory Acceptance Test (FAT) working with the Vanrx technical services team in Vancouver.
The SA25 is shipped from Vancouver to WuXi,China, where it is installed and the Site Acceptance Test is completed—all in one month.
The WuXi Biologics team completes the SA25's commission, installation qualification, operational qualification and performance qualification, as well as the vapour-phase hydrogen peroxide decontamination cycle development.
Media fills complete
The WuXi Biologics team completes media fills into pre-filled syringes and vials.
First GMP 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?
|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.|
|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.
Find out more about aseptic filling with WuXi Biologics at wuxibiologics.com.