World Quality Day | Building Client Trust Through Quality Excellence

World Quality Day | Building Client Trust Through Quality Excellence

Every molecule carries a journey from development to manufacturing, along with the trust of our partners and the hope of patients. At WuXi Biologics, we earn that trust through consistent quality at every step.

November 12 marks World Quality Day. Quality is at the heart of our competitive strength and the foundation of the long-standing trust global clients place in WuXi Biologics.

WuXi Biologics World Quality Week Activities

Every Time | Proven Quality. Earned Trust.

The value of quality ultimately shows in patient benefit and client recognition. Every batch of product carries a patient's hope for health and a client's trust.

That trust has been built on client audits and regulatory inspections. On the regulatory side, as of the end of June 2026, WuXi Biologics has successfully passed 49 regulatory inspections, including 23 by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and has received 166 facility license approvals. On the client side, the company has passed more than 2,000 GMP quality audits by global clients, including over 280 audits by EU Qualified Persons. These records are built on years of ongoing external scrutiny, while quality requirements are ultimately delivered through consistent execution, every day and in every project.

Drug Substance Facility 8 (MFG8)

This year, the Drug Substance Facility 8 (MFG8) at the Hebei site passed the FDA's Pre-License Inspection, and the Mashan site in Wuxi successfully passed an FDA on-site GMP compliance inspection. Both once again demonstrate WuXi Biologics' commitment to the highest international quality standards and operational excellence. Today, the company operates 26 drug substance and 19 drug product manufacturing facilities worldwide, and its world-class quality system and compliance capabilities are the cornerstone of winning
client trust.

Wuxi Mashan site

As more programs on its integrated platform advance into late stages and commercialization, regulatory inspections will become an increasingly regular part of the journey across sites and programs. Each inspection puts the strength, consistency, and long-term effectiveness of the entire quality system to the test. With global demand for commercial biologics continuing to grow and regulatory requirements rising, WuXi Biologics will continue to leverage its robust quality system, global manufacturing network and flexible, reliable supply capabilities to deliver high-quality, efficient commercial manufacturing services to partners, helping innovative biologics reach more patients around the world faster and more reliably.

Every Day | Making "Always Ready" the Standard

Regulatory inspections, client audits, and product approvals are periodic tests of quality. An inspection lasts only a few days, but quality is determined by every day that comes before it.

Was an abnormal signal caught in time? Was an investigation grounded in science and evidence? Did the corrective and preventive action (CAPA) system truly resolve the problem? Could a similar risk arise in other processes, equipment or sites? The answers lie in everyday work.

Drug regulators around the world have established comprehensive laws, regulations, and guidelines for the filing and manufacturing of biologics. WuXi Biologics treats compliance with these requirements as one of its top priorities and keeps pace with industry and technology developments. On that basis, it has built a unified global Pharmaceutical Quality System (PQS) that covers its manufacturing sites worldwide. The company also rigorously audits every site against its internal quality standards. A dedicated department analyzes the audit results and designs targeted solutions, coordinating with on-site Quality Assurance (QA) and Quality Control (QC) teams to ensure improvements are implemented effectively.

As inspection models evolve, WuXi Biologics reviews its quality system against higher standards and builds quality into daily execution through three elements: risk prevention, sustained readiness, and rapid response. The company continuously monitors risk trends, conducts mock inspections, builds a traceable body of evidence, and maintains clear risk escalation and decision-making mechanisms.

When being "inspection-ready at all times" becomes part of everyday practice, a strong culture of quality takes root.

Every Employee | One Team. One Shared Quality Commitment.

Building quality takes every colleague at every step, and it depends on unified standards.

The PQS provides that foundation, turning proven experience into methods that can be replicated and scaled. Regardless of which site runs a client's project or which market it serves, the same quality standards apply.

The value of a global quality network lies in turning one site's experience into shared knowledge across the entire network. As the company's global network expands, lessons from inspections, deviation investigations, and risk control at one site can be quickly shared with others. A problem identified by one team can prompt the whole network to review and prevent similar risks. Through harmonized standards and cross-site collaboration, local experience becomes globally consistent quality capability. Digitalization offers new possibilities for capturing, sharing and reusing quality knowledge, helping teams and sites facing similar issues draw on validated organizational experience to make more science-based, consistent judgments.

WuXi Biologics places great importance on building a quality-centered culture, continually reinforcing quality awareness in the rollout of quality standards and in day-to-day operations. The company has set up a dedicated training center within its quality team to ensure that training policies and annual training plans are effectively developed and implemented. The quality training system covers professional competency training and the promotion of product quality practices.

New hires in R&D, manufacturing, quality and related roles receive classroom training on Good Manufacturing Practice (GMP), manufacturing and quality control, along with hands-on laboratory training. Current employees also complete annual training and role-based skills development, continually raising the level of quality management. The company also provides an online training platform where all employees can take relevant courses on their own to strengthen their quality management skills.

Each colleague's dedication, consolidated through standards, mechanisms and tools, builds into a global organizational capability.

Closing

Quality is strengthened through the work of every day, upheld by the dedication of every employee, and trust is affirmed through every audit and inspection.

On this World Quality Day, WuXi Biologics pays tribute to every colleague who upholds quality. Their dedication, day after day, has made quality the most reliable common language between WuXi Biologics and its global partners, helping every collaboration stand the test of time. Looking ahead, WuXi Biologics will continue to build on quality to enable global partners' commercial success and lay a stronger foundation for the company's rapid growth and long-term value creation.

About WuXi Biologics

WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics - from concept to commercialization - for the benefit of patients worldwide*.

With over 14,000 employees in China, the United States, Ireland, Germany, and Singapore, including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence, WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients' needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of June 30, 2026, WuXi Biologics is supporting 1064 integrated client projects, including 78 in Phase III and 28 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.

WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while demonstrating exemplary Environmental, Social and Governance (ESG) practices. Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts, and promote responsible practices that empower the entire value chain.

For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

*The winner of the "2026 Biologics CDMO of the Year" (Large CDMOs) (Life Science Connect / Outsourced Pharma)

*The winner of the "2026 Best Contract Development & Manufacturing Organization Award" (ABEA)

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