• Successfully completed multiple 16,000-liter scale PPQ productions, once again demonstrating that single-use bioreactors can match the production efficiency of traditional stainless steel bioreactors.
• Obtained HPRA GMP certification, highlighting that the company's new operation global base has established a world-class quality system.

Dundalk, Ireland, December 6, 2024 /PR Newswire/ -- Wuxi Bio, a global leading contract research, development and manufacturing (CRDMO) service company (2269.HK), today announced several important business advancements at its advanced green production base in Ireland. The company's biopharmaceutical bulk drug production plant seven (MFG7) has completed multiple batches of 16,000-liter scale process performance qualification (PPQ) production. This base has achieved a 100% success rate in PPQ production for two projects concurrently and has also received GMP certification from the Irish Health Products Regulatory Authority (HPRA) for all three biopharmaceutical bulk drug production facilities. These milestones also emphasize the key role of the Irish base in providing world-class biopharmaceutical solutions within Wuxi Bio's global production network.

By combining four 4,000-liter single-use bioreactors, Wuxi Bio's Irish base achieved a PPQ production scale of 16,000 liters per batch, which is also one of the largest scale fed-batch cell culture processes globally using single-use bioreactors. This milestone not only sets a new benchmark for the entire biopharmaceutical industry and implements the esg concept but also proves the company's ability to achieve cost control comparable to large-scale stainless steel bioreactors.

In October of this year, wuxi bio's multi-product manufacturing site in Ireland successfully passed the comprehensive on-site inspection by HPRA, covering the GMP compliance requirements for data management, process control, personnel management, production, storage, and analysis. This GMP certification further confirms the commitment to adhere to regulatory standards. In the future, wuxi bio's Ireland site will continue to provide clinical and commercial biopharmaceutical bulk production services to global clients, benefiting a wide range of patients. Up to now, wuxi bio has successfully passed nearly 40 inspections from major global pharmaceutical regulatory institutions and has obtained 67 licenses.

Dr. Chen Zhisheng, CEO of wuxi bio, stated: "These milestones not only reflect the exceptional speed, agility, and execution of our Ireland team but also further demonstrate the company's unwavering commitment and determination to high-quality standards, innovative practices, and sustainable development. The success of the Ireland site further strengthens our global production network, empowering the company to help global clients develop and produce more high-quality, life-saving therapies, benefiting patients worldwide."

Since it began operation in March 2022, wuxi bio's Ireland site has rapidly become a leader in the global biopharmaceutical field. The site has over 760 professionals and combines advantages such as cutting-edge design and construction, eco-friendly concept, and scalability. It features three industry-leading biopharmaceutical bulk production facilities, equipped respectively with 48,000-liter perfusion cell culture bioreactors (MFG7) and 6,000-liter perfusion process bioreactors (MFG6.1 and MFG6.2).

The GMP-certified facility provides clinical and commercial production services with world-class quality and efficiency, and has obtained ISO 50001 (Energy Management System), ISO 14001 (Environmental Management System), and ISO 45001 (Occupational Health and Safety Management System) certifications, highlighting the company's strong commitment to sustainable development. The wuxi bio Ireland site also received the Best Facility Award from the International Society for Pharmaceutical Engineering (ISPE) in 2023.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global open-access biologics technology platform offering end-to-end solutions to empower and accelerate biologics discovery, development, and manufacturing. The company's services are designed to help its partners achieve their goals at all stages of the biologics life cycle, from concept to commercial manufacturing. WuXi Biologics' innovative platforms and solution-focused services are designed to help customers bring innovative biologics products to market faster and more efficiently, ultimately benefiting patients worldwide.

Wuxi Bio has over 12,000 employees in China, the USA, Ireland, Germany, and Singapore. Through Wuxi Bio's professional services team, as well as advanced technology and deep insights, the company provides customers with efficient and cost-effective solutions for biopharmaceuticals. As of the end of June 2024, Wuxi Bio has assisted customers in developing and producing a total of 742 comprehensive projects, including 16 commercial production projects (excluding new crown projects and inactive projects).

Wuxi Bio views environmental, social and governance (esg) as an important part of business development and corporate spirit, and is committed to becoming a global leader in the biopharmaceutical CRDMO field by applying greener and more eco-friendly new generation biopharmaceutical technologies and energy to lead industry development. The company has established an esg committee led by the CEO to implement the global strategy and practice its commitment to sustainable development. For more information, please visit:.

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