Recent developments
Regulatory access broadened
AGC Biologics' Seattle facility earned GMP certification from Brazil’s Anvisa, extending supply reach. Waskyra™ gene therapy gained U.S. and EU approvals with AGC providing LVV and cell manufacturing. WuXi Biologics secured MHRA GMP certification for ophthalmic fill‑finish, and separately obtained GMP certification from Türkiye’s TITCK for multiple Wuxi sites.
Capacity and footprint
Merck began construction of a $3 billion pharmaceutical facility in Virginia. Lilly will open a new Gateway Labs site in Philadelphia. WuXi Biologics signed an MoU with the Qatar Free Zones Authority for an integrated CRDMO center. Terumo completed the acquisition of a Drug Product Plant in Leverkusen from WuXi.
Process and platform innovations
WuXi Biologics introduced the PatroLabTM digital twin platform integrating real‑time PAT and in‑silico modeling. Toray launched a high‑efficiency separation membrane module to reduce fouling, buffer use, and footprint in purification. Evonik added the Noblyst® F catalyst portfolio for flow, MaxiPure® Polysorbate 80 for injectables, and a novel lipid nanoparticle (LNP) platform with Ethris.
Partnerships and ESG
WuXi Biologics signed a license and research service agreement with Vertex for a trispecific T‑cell engager. It formed a strategic partnership to develop and manufacture SND006 with Sinorda and agreed on development and manufacturing of next‑generation fusion protein programs with HanchorBio. Brenntag’s sole distribution partnership with Seqens expands EU non‑GMP intermediates access. WuXi reported EcoVadis Platinum Medal, ISO 20400 certification, CDP “A” ratings for climate and water, and inclusion in the S&P Global Sustainability Yearbook 2026, plus the Hang Seng Corporate Sustainability Benchmark Index.