Recent developments
CDMO deal flow
WuXi Biologics expanded its pipeline support via a license and research service agreement for a trispecific T‑cell engager with Vertex, strategic collaboration with HanchorBio on multi‑functional fusion proteins, and a partnership with Sinorda Biomedicine on SND006. The company also signed a Memorandum of Understanding with the Qatar Free Zones Authority to establish an integrated CRDMO center in the Middle East.
Quality and capacity
WuXi Biologics secured GMP certifications from the UK Medicines and Healthcare products Regulatory Agency for commercial ophthalmic biologics and GMP certification from Türkiye’s TITCK for multiple Wuxi sites. Terumo completed the acquisition of a Drug Product Plant in Leverkusen, expanding EU fill‑finish capacity.
Advanced therapy progress
AGC Biologics supported approvals of Waskyra, an ex vivo gene therapy for Wiskott‑Aldrich syndrome, demonstrating CDMO roles across vectors and cell processing. A transatlantic partnership between BBG Advanced Therapies and CELLforCURE created integrated ATMP manufacturing options for US‑EU programs.
Process and platforms
Digitalization and purification advanced. WuXi Biologics unveiled its PatroLab digital twin platform for real‑time PAT, in‑silico modeling, and predictive control. Toray introduced a high‑efficiency separation membrane module to mitigate fouling in gene therapy purification. Evonik and Ethris partnered on a novel LNP platform targeting thermostability and local retention.
Inputs and delivery
Upstream and formulation inputs evolved: Evonik launched GMP‑grade EUDRACAP colon capsules for ileo‑colonic delivery with associated CDMO services, introduced MaxiPure Polysorbate 80 for injectable stability, and released Noblyst F catalysts for flow applications. Exclusive distribution with Seqens strengthens European supply of non‑GMP pharmaceutical intermediates.