Recent developments
Capacity buildout
Manufacturing footprints widened as Merck’s $3 billion facility in Virginia advanced capacity. Fill-finish optionality in Europe grew with Terumo’s acquisition of a WuXi Biologics plant in Germany. Regional diversification continued via WuXi Biologics’ agreement with Qatar Free Zones Authority to establish a Middle East CRDMO center.
Advanced therapies scale
ATMP delivery progressed as AGC Biologics supported U.S. and EU approvals for Waskyra gene therapy for Wiskott-Aldrich syndrome. A transatlantic cell and gene therapy network formed through BBG Advanced Therapies and CELLforCURE, easing multinational trials and scale-up.
Process innovations
Digital and hardware upgrades targeted yield, control, and cost. WuXi Biologics introduced the PatroLab digital twin platform for real-time PAT and predictive control. Toray’s high‑efficiency separation membrane module aims to de-bottleneck purification in next‑gen modalities. Evonik and Ethris partnered on a thermostable LNP platform for nucleic acid delivery.
Pipeline outsourcing
Deal flow underscored CDMO-enabled discovery-to-IND paths. WuXi Biologics signed a license and services agreement with Vertex for a trispecific T‑cell engager in autoimmune disease. A strategic partnership with Sinorda Biomedicine advances SND006 and IND preparations, alongside programs with HanchorBio. Supply resilience improved via Brenntag’s exclusive European distribution with Seqens, complemented by Croda’s tie-up with Amino and MGC’s planned distribution of long‑chain RNA in Japan.
Quality and ESG
Regulatory credibility remained central as WuXi Biologics secured UK MHRA GMP certification for ophthalmic biologics. Further capacity passed inspection with GMP approvals from Turkey’s TITCK across multiple Wuxi facilities. Sustainability frameworks deepened with WuXi Biologics’ third consecutive EcoVadis Platinum. Procurement governance advanced via ISO 20400 certification and CDP “A” ratings for climate and water.