WuXi Biologics Launches a New GMP Commercial Drug Product Facility

Rhea-AI Summary

WuXi Biologics has launched a new GMP drug product facility in Wuxi, China, enhancing its drug production capabilities. The 12,000m² facility, known as DP2, can produce up to 60 million vials annually for biologics and features advanced isolator filling lines. This expansion supports high-efficiency production and flexible drug manufacturing solutions, meeting evolving regulatory requirements. Additionally, a new automated Drug Product Packaging Center has been opened to improve packaging efficiency for both clinical and commercial projects. This initiative reflects WuXi Biologics' commitment to innovation in biologics manufacturing.

Positive

• Launch of a new GMP drug product facility (DP2) in Wuxi, China.
• Increased production capacity of up to 60 million vials annually.
• State-of-the-art technology for high-speed production and flexibility in manufacturing.
• New fully automated vial packaging line enhances efficiency.
• Commitment to meeting global regulatory requirements with innovative technologies.

Negative

• None.

• Enhances drug product services for projects at various stages, with an emphasis on late and commercial stage production
• Increases up to 60 million vials for commercial drug production per year
• Consolidates WuXi Biologics' pioneering the application of innovative technologies such as single-use and automation

WUXI, China, Oct. 31, 2021 /PRNewswire/ -- WuXi Biologics ("WuXi Bio") (2269.HK), a global company with leading open-access biologics technology platforms, announced it has successfully launched the GMP operation of its new drug product facility located in Wuxi, China, which is the eighth operational drug product facility in the global network of WuXi Biologics.

The 12,000m² drug product facility, called DP2, features a state-of-the-art isolator filling line for the continuous high-speed production of wide size range – from 2R to 50R of liquid and 20m²/40m² of lyophilization. Leveraging its innovative design, the facility can switch rapidly between different specifications to maximize its filling efficiency, providing flexible drug product manufacturing solutions to meet customers' needs. DP2 will increase up to 60 million vials for commercial drug production of biologics per year. This facility serves as an example of WuXi Biologics' implementation of single-use technology as it utilizes disposable peristaltic pump filling systems and sterile filtration systems in pre-use post sterilization integrity testing (PUPSIT), which meet current and evolving global regulatory requirements.

With its advanced layout and equipment, the facility effectively eliminates cross-contamination and ensures product sterility while accelerating drug product services across multiple modalities – such as monoclonal antibodies, bispecifics and fusion proteins – and enables the company to initiate any client project within four weeks. The application of both single-use and stainless-steel formulation systems helps reduce energy consumption, resulting in greater productivity and lowered environmental impact.

In addition, WuXi Biologics has also launched the GMP operation of a new Drug Product Packaging Center (DPPC) which includes the company's first fully automated vial packaging line. This packaging line is designed to meet U.S. FDA, EMA and China's NMPA GMP requirements and will leverage new technologies – including anti-forgery drug tracking as well as automatic intelligent labeling and packaging – to not only provide customized end-to-end manufacturing services for clients, but also accelerate the process of high-volume clinical and commercial projects.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "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. 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."

Dr. Chen said, "Our business strategy in both building and acquiring new facilities has been driven by global customer demand and the robust biologics market. Expanding our capacity and capabilities around the world embodies our commitment to our customers as they pursue innovative ideas and achieve advances that benefit patients worldwide. As a contributor to the global healthcare industry, WuXi Biologics is committed to making more high-quality biologics available and affordable for patients in need."

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company's history and achievements demonstrate its commitment to providing a truly ONE-stop service offering and strong value proposition to its global clients.

The company is currently conducting on behalf of its clients and partners (as of June 30, 2021) a total of 408 integrated projects, including: 212 in pre-clinical development stage; 160 in early-phase (phase I and II) clinical development; 32 in late-phase (phase III) development; and 4 in commercial manufacturing. With a total estimated capacity exceeding 430,000 liters for biopharmaceutical production planned after 2024 in China, Ireland, the U.S., Germany, and Singapore, WuXi Biologics will continue to provide its biomanufacturing partners with a robust and premier-quality global supply chain network.

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of its ethos and business strategy and aims to become a global ESG leader in biologics manufacturing. We use next-generation clean biomanufacturing technologies and utilize cleaner energy sources. We have also established an ESG committee led by the CEO to increase efficiency while advancing our commitment to sustainability. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

Contacts

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SOURCE WuXi Biologics

FAQ

What is the significance of the new GMP drug product facility announced by WuXi Biologics?

The new GMP drug product facility, DP2, enhances WuXi Biologics' capacity to produce up to 60 million vials annually, supporting global clients in biologics.

How does the new facility impact WuXi Biologics’ production capabilities?

The new facility increases production efficiency and flexibility, allowing rapid switching between different specifications to meet client needs.

What new technologies are incorporated in WuXi Biologics' drug product facility?

The facility utilizes single-use technology, automated processes, and advanced isolator filling lines to ensure product sterility and compliance with global regulations.

What are the goals of WuXi Biologics with the launch of the new facilities?

WuXi Biologics aims to support high-yield, high-efficiency drug production and meet increasing global demand in the biologics market.

When was the new GMP drug product facility launched by WuXi Biologics?

The new GMP drug product facility was launched on October 31, 2021.