Recent developments
Capacity expansion moves
CDMOs expanded capacity. WuXi Biologics completed structural works at its Chengdu microbial site with fermentation and fill‑finish, targeting 2026 GMP release. Evonik will add downstream fermentation and processing at its Fermas site in Slovakia. In Japan, Evonik and Higuchi opened an Open Pharma Lab in Yokohama for oral‑dosage formulation support.
Regulatory and compliance
WuXi Biologics received MFDS GMP certification in South Korea for a commercial bispecific; its Wuxi DP5 and DPPC also gained UK MHRA GMP certifications for an ophthalmic biologic. AGC Biologics’ Seattle site secured Anvisa GMP certification. Waskyra gene therapy obtained U.S. and EU approvals.
Digital and process tech
Digital and process technologies matured. WuXi Biologics launched the PatroLab digital twin for real‑time PAT and control, and reported record 2025 results citing digital‑native operations and a client portal. Toray introduced a high‑efficiency separation membrane module to cut clogging, buffer use and footprint in purification.
Collaborations and pipelines
Pipeline outsourcing stayed active. WuXi Biologics signed a license and research agreement with Vertex for a trispecific T‑cell Engager; partnered with Sinorda Biomedicine on bispecific SND006; and agreed with HanchorBio to develop multifunctional fusion proteins. It also teamed with Earendil Labs to advance bispecifics, multispecifics and ADCs.
Regionalization and market trends
Regionalization and market signals mixed. Development lenders backed Biovac to build Africa’s first end‑to‑end multi‑vaccine plant. Brenntag and Seqens formed a European distribution partnership for non‑GMP pharmaceutical intermediates. SEQENS’ CELLforCURE sought a buyer for its Les Ulis CGT site amid funding slowdowns and U.S. bioproduction shifts.