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2021-11-03| China

WuXi Biologics Launch Its Largest GMP Drug Facility and First Automated Vial Packaging Line

by Tyler Chen
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WuXi Biologics launched its largest GMP drug product facility and the first fully automated vial packaging line on November 1. The site marks the 8th drug facility under WuXi Biologics and is expected to expand the vial capacity for commercial use to 60 million per year.

 

WuXi’s Largest GMP Drug Product Facility

The 12,000 square meters site is called DP2. It is equipped with the state-of-the-art isolator filling line for the high-speed production of a wide size range and uses disposable peristaltic pump filling systems and sterile filtration systems in pre-use post sterilization integrity testing (PUPSIT).

WuXi Biologics said DP2 will increase vial production to 60 million per year and can eliminate cross-contamination and sterilize products while speeding up the development process in monoclonal antibodies, bispecific, and fusion proteins.

 

First Automated Vial Packaging Line

The Chinese firm also opened a Drug Product Packaging Center (DPPC). The new facility incorporates anti-forgery drug tracking, automatic intelligent labeling, and packaging to provide end-to-end drug production services. It is designed to meet FDA, EMA, and China’s NMPA’s GMP requirements.

“We’re excited about the successful GMP launch of the first fully automated vial packaging line as well as DP2, the largest commercial drug product facility at WuXi Biologics.” Dr. Chris Chen, CEO of WuXi Biologics continues to say, “these will allow us to further provide high-yield, high-efficiency, and high-quality drug product services to support our global clients’ clinical trials, product registration, and commercial authorization.”

 

Deals With Pfizer and Bayer

In the last two years, WuXi Biologics has struck deals with Bayer and Pfizer China to acquire their drug production plants.

In December 2020, the firm acquired MFG19 located in Wuppertal, Germany for $183.3 million (€150 million) from Bayer. The site takes up around 30,000 square meters and is equipped with 3 x 1,000L perfusion and 6 x 2,000L fed-batch capacity with independent downstream suites. The site will help its Leverkusen facility deliver COVID-19 vaccines and biologics.

Another deal was made in March 2021, which saw the firm acquire production facilities (MFG20/DP9/DP10) in Hangzhou, China for an undisclosed sum from Pfizer China. The facilities were originally built for producing biosimilars that would be sold in China. The site is 50,000 square meters, including DS capacities equipped with 2x2000L single-use bioreactors expandable to 4x2000L (MFG20) and DP capacities of vial filling (DP9) and pre-filled syringe (DP10).

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