WuXi Biologics bolsters European biomanufacturing at CPHI Milan 2026
- European biologics market was valued at US$123.75 billion in 2025 and is projected to reach US$269.65 billion by 2035 at a CAGR of 8.1% (2026–2035).
- WuXi Biologics has passed 49 regulatory inspections, including 23 by the FDA and EMA, holds 166 facility licence approvals and has undergone more than 2,000 GMP client audits, including over 280 by EU Qualified Persons.
- European capacity includes Dundalk, Ireland with 54,000 L drug‑substance capacity and Wuppertal, Germany with 12,000 L single‑use capacity, expandable to 24,000 L.
- The company supports 1,064 integrated projects (221 bispecific/multi‑specific and 328 ADCs), can initiate projects within four weeks, complete 66 DNA‑to‑IND projects within six months, and has completed technology transfer to PPQ in as little as 3.5 months with a 100% PPQ success rate.
Market context and event engagement
Europe’s biologics sector is growing under demographic and disease‑burden pressures; the market was estimated at US$123.75 billion in 2025 and is forecast to reach US$269.65 billion by 2035. At CPHI Milan 2026, WuXi Biologics engaged partners to demonstrate its CRDMO capabilities for advancing complex biologics from development to supply.
Quality and regulatory track record
WuXi Biologics cites a regulatory record of 49 inspections (23 by FDA and EMA), 166 facility licence approvals and over 2,000 GMP client audits, including more than 280 by EU Qualified Persons. Integrated MSAT, quality, manufacturing and project teams are presented as the operational basis for process transfers, PPQ and ongoing production.
European operations and network strategy
Europe is positioned as a strategic region within a global network that also covers the US, China and Singapore. Dundalk (Ireland) is described as a commercial manufacturing hub with 54,000 L drug‑substance capacity across perfusion and fed‑batch platforms, while Wuppertal (Germany) offers 12,000 L single‑use capacity with potential to expand to 24,000 L and supports clinical to commercial programmes.
Speed, platforms and project metrics
The company reports support for 1,064 integrated projects, including 221 bispecific/multi‑specific and 328 ADC projects, and capability to initiate projects within four weeks. It highlights 66 DNA‑to‑IND projects achieved within six months, technology transfer to PPQ in as little as 3.5 months and a reported 100% PPQ campaign success rate, alongside platform claims for cell‑line titers and high‑concentration subcutaneous formulation.
Integrated CRDMO positioning
WuXi Biologics frames its integrated CRDMO platform, global dual‑sourcing and regional European capacity as a response to rising demand for quality, supply resilience and faster development of complex biologics.
Source: WuXi