WuXi Biologics Commenced Process Validation in MFG2

• Produced 7 batches at 6,000L/12,000L bioreactor scale for three programs, the largest scale cell culture operations in China at 100% success rate in MFG2, the largest biologics manufacturing facility globally leveraging single-use technology

• Process validation in MFG2 is a key milestone of the innovative “scale-out”, instead of “scale-up” approach for large scale manufacturing

• Combining multiple single-use bioreactors achieved competitive COGS to traditional stainless steel bioreactor facilities

WuXi Biologics a leading global open-access biotechnology platform company, offering end-to-end solutions for discovery, development and manufacturing, today announced that a process validation campaign at the 6,000L scale has been initiated to support global product registration and launch for a key partner in the fed-batch facility of MFG2, the 2nd cGMP manufacturing facility of WuXi Biologics.

The 500,000 sq. ft. state-of-the-art facility, the largest global operation of its kind deploying 14 x 2,000L single-use bioreactors, was completed in the record time of 18 months from the conceptual design to its inaugural cGMP campaign. It implements the pioneering approach of combining multiple 2,000L bioreactor harvests to enable production runs to reach either 6,000L or 12,000L (i.e. “scale-out” instead of “scale-up”), a strategy that was executed under an accelerated construction timeline, at significantly lower CAPEX, and with the elimination of bioreactor scale-up challenges. Since coming online in December 2017, a total of seven batches for three different programs at either the 6,000L or 12,000L scale have been produced. This facility also successfully passed the client’s pre-process validation audit, a critical step in the final stage of product development prior to its BLA filing.

“We are excited to achieve two memorable milestones for WuXi Biologics. The first is to attain definitive affirmation of our innovative approach to large scale commercial manufacturing. With this design concept, we will reach comparable COGS of commercial scale stainless steel bioreactor-based facilities, only much more expeditiously and with less capital investment. By this strategy, we will have approximately 220,000L of bioreactor capacity to provide our global partners with a robust supply chain of premier quality in 2021,” said Dr. Chris Chen, Chief Executive Officer of WuXi Biologics. “The 2nd milestone is that we have successfully run multiple campaigns at both 6,000L and 12,000L scales, the largest scale operations in China. Possessing widely acclaimed technical capabilities and unparalleled capacities, we continue to transform how complex biologics are developed and manufactured globally.”



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