How quality, supply resilience, manufacturing excellence and innovation are supporting the next generation of biologics.

MILAN, Oct. 9, 2026 /PRNewswire/ -- Europe's biologics sector is expanding as ageing populations and the rising burden of chronic, autoimmune and rare diseases increase demand for advanced therapies. The European biologics market was valued at an estimated US$123.75 billion in 2025 and is projected to grow at a CAGR of 8.1% from 2026 to 2035, reaching approximately US$269.65 billion by 2035, underscoring the need for faster development, dependable manufacturing and resilient regional supply.

That urgency is on display at CPHI Milan 2026, which brings together more than 62,000 pharmaceutical professionals and 2,900 exhibitors. During the event, Wuxi Biologics engaged extensively with global biopharma partners, demonstrating how its innovative technologies can advance complex biologics from development to reliable supply.

As biologics pipelines become more complex and supply resilience grows in importance, biopharmaceutical companies are seeking partners that can combine quality, manufacturing excellence, global reach, speed and innovation. WuXi Biologics brings these capabilities together through its integrated CRDMO platform and strategically positioned operations in Europe.

Superior Quality: Building Confidence from Development to Supply

For biologics clients, quality and execution are closely connected. A strong quality system must be supported by the operational discipline to transfer processes, complete qualification activities and manufacture consistently across programs and sites.

As of June 2026, WuXi Biologics had passed 49 regulatory inspections, including 23 conducted by the FDA and EMA, secured 166 facility license approvals, and passed more than 2,000 GMP quality audits by global clients, including over 280 audits by EU Qualified Persons.

This regulatory and client-audit track record provides an important foundation, but execution is demonstrated through delivery. Integrated MSAT, quality, manufacturing and project teams work together to manage technology transfer, PPQ and ongoing production. Consistent governance and shared technical standards help programs move across development and manufacturing stages with reduced handover risk.

For clients, superior quality and execution provide confidence that a program can progress from a promising molecule to repeatable, compliant and reliable supply.

Global Network: Strengthening Supply Resilience and Agility

Companies are evaluating supplier concentration, single-site dependency, region-for-region strategies and the ability to access alternative manufacturing pathways with quality and technical consistency.

WuXi Biologics operates a global manufacturing network spanning Ireland, Germany, the United States, China and Singapore. Globally unified quality systems, integrated technology platforms and coordinated execution connect these locations as one robust network.

At the center of this approach is Global Dual Sourcing, designed to build supply agility by aligning quality, analytics and technology transfer across global sites. Leveraging proven experience from across the network, integrated technical teams and unified project governance enable manufacturing processes to be transferred, scaled and replicated while maintaining product quality, comparability and execution consistency. This allows customers to evaluate manufacturing pathways according to program requirements, scale, market needs and supply strategy.

Strengthening Manufacturing in Europe

Europe plays a strategic role within this global network. Regional manufacturing options can bring production closer to key markets and regulatory environments, while connection to a broader network provides access to shared platforms, quality systems, technical expertise and supply optionality. WuXi Biologics' operations in Dundalk, Ireland, and Wuppertal, Germany, provide complementary capabilities within this model.

Dundalk, Ireland:

An Established Commercial Manufacturing Hub

Dundalk site is WuXi Biologics' established commercial manufacturing hub in Europe. The site operates under an HPRA GMP manufacturing license, supports EMA-approved commercial products and has served more than 10 clients. It provides 54,000 L of drug-substance manufacturing capacity across perfusion and fed-batch platforms. In 2026, the site secured multiple new large-scale manufacturing projects and initiated the associated technology transfers.

Dundalk site has demonstrated the successful execution of WuXi Biologics' Global Dual Sourcing strategy. Across multiple programs, the site has supported same-scale transfers, scale-up transfers and process-enhancement transfers while maintaining product comparability and consistent quality standards. Successful PPQ execution across sites and support for EMA-approved commercial products further demonstrate the ability to transfer and replicate manufacturing processes within the network while ensuring reliable supply.

The site has also received industry recognition for its operational performance. It received the ISPE Facility of the Year Award in 2023. In 2026, WuXi Biologics Ireland received the Overall Excellence in Life Sciences Award, while its MSAT team was named Life Sciences Team of the Year. Together, these milestones reflect Dundalk's development into a proven commercial manufacturing operation within both the European life-sciences ecosystem and WuXi Biologics' global network.

Wuppertal, Germany:

Expanding Manufacturing Agility

Complementing Dundalk, WuXi Biologics' Wuppertal site offers flexible drug-substance manufacturing at different scales and stages of development, backed by technology transfer, MSAT, quality-control and logistics capabilities across the regional platform. The site currently includes 12,000 L single-use bioreactors capacity, with future expansion potential to 24,000 L. Supporting functions include GMP-certified quality-control laboratories and integrated warehousing capabilities.

Located in North Rhine-Westphalia, one of Europe's leading life-sciences regions, Wuppertal supports clinical, late-stage and commercial programs. Together, Dundalk and Wuppertal provide complementary European capabilities connected by globally aligned technology, quality and execution systems.

Unmatched Speed: Accelerating Progress with Certainty

Reliable manufacturing must be matched by the ability to move programs forward efficiently from development through scale-up and commercial supply. True acceleration comes from combining speed, quality and execution certainty. WuXi Biologics brings together platform technologies, mature technology-transfer infrastructure, integrated CMC expertise and coordinated manufacturing execution to support faster, de-risked progress across the product lifecycle.

As of June 2026, WuXi Biologics supported 1,064 integrated projects, including 221 bispecific and multi-specific antibody projects and 328 ADC projects. Complex modalities represented more than half of the portfolio, giving the company broad experience in translating novel science into scalable processes.

Its integrated CRDMO platform has empowered more than 66 DNA to IND projects within six months, supported by a 100% IND-filing success rate, while its global capacity and platform readiness enable the company to initiate any client project within four weeks. Across WuXi Biologics' manufacturing network, technology transfer to PPQ has been completed in as little as 3.5 months. The company has also maintained a 100% PPQ campaign success rate, with 34 PPQs scheduled for 2026 and another 30 for 2027.

Technology platforms help underpin this execution. WuXia™ TrueSite, the fourth generation of the company's cell-line platform, uses targeted integration to deliver predictable, stable expression. It has achieved 8-12 g/L titers for monoclonal antibodies and 7-10 g/L titers for bispecific antibodies, with more than 99% of clonal cell lines maintaining stable protein expression after 60 generations, and can support an IND-ready CMC timeline within six months.

For high-dose delivery, WuXiHigh™ 2.0 integrates formulation, device and manufacturing development for patient-friendly subcutaneous therapies. The platform supports protein concentrations up to 240 mg/mL and viscosity reductions of up to 90%, while connecting high-throughput formulation work with fill-finish, drug-device combination and large-volume delivery options.

Together, these capabilities demonstrate that sustainable speed is not simply about shortening timelines. It comes from integrating proven platforms, development expertise, technology-transfer experience and manufacturing discipline to move complex programs forward with control and confidence.

Integrated CRDMO Platform: Advancing Complex Biologics to Reliable Supply

The direction of biomanufacturing is clear: supply strategies are becoming more regional and resilient, molecules are becoming more complex, and customers expect reliable execution from development through commercial supply. Meeting those demands requires more than capacity. It requires quality confidence, a connected global network, manufacturing excellence, execution speed and integrated technology.

Through its integrated CRDMO platform and European operations, WuXi Biologics is helping clients turn scientific progress into dependable clinical and commercial supply. Dundalk site provides established commercial manufacturing, while Wuppertal site adds flexibility for clinical, late-stage and commercial programs. Both are part of a broader network designed to combine global scale with regional options.

In the next era of biologics manufacturing, success will depend not simply on securing capacity, but on choosing a partner with quality confidence, execution excellence, network flexibility and technologies to move complex programs forward with certainty.

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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