Recent developments
Biologics CDMO scale
Biologics CDMO scale expanded as WuXi Biologics reported record 2025 results and signed with the Qatar Free Zones Authority to establish a Middle East hub. AGC Biologics’ Seattle site gained Anvisa GMP certification, and the company supported U.S. and EU approvals for the Waskyra gene therapy. Upstream demand signals included Merck’s pharmaceutical facility construction in Virginia.
Digitalization and quality
WuXi Biologics accelerated digital-native operations and unveiled the PatroLab digital twin platform for real‑time PAT, predictive control, and QbD. Quality credentials were reinforced by MHRA GMP certification for commercial ophthalmic biologics.
Pipeline and partnerships
Pipeline building featured a license agreement with Vertex Pharmaceuticals on a trispecific T‑cell engager, plus collaborations with Earendil Labs and HanchorBio on complex antibodies and fusion proteins. WuXi Biologics also partnered with Sinorda Biomedicine on an IBD bispecific, while KYORIN and UBE signed an exclusive license for novel small‑molecule candidates.
Process technology shifts
Process technology progressed: Saltigo highlighted custom chemical synthesis and scale-up spanning hydrogenation, fluorination, and flow; Evonik’s EUDRACAP colon capsules gained recognition for targeted ileo‑colonic delivery; and Toray introduced a high-efficiency separation membrane module to reduce purification costs in biologics.
Restructuring and supply
Restructuring affected advanced therapies as CELLforCURE began seeking a buyer for its Les Ulis site amid funding headwinds. Upstream distribution tightened through Brenntag’s sole distribution partnership with Seqens for non‑GMP intermediates. Recognition included AGC Pharma Chemicals’ wins at the CDMO Leadership Awards 2026, while inputs broadened via Croda’s strategic supply partnership with Amino.