Recent developments
Regulatory milestones
AGC Biologics’ Waskyra ex vivo gene therapy secured U.S. and EU marketing authorizations. WuXi Biologics’ Wuxi DP5 and DPPC gained MHRA GMP certifications for an ophthalmic biologic, and MFG1/MFG2/DP5 passed TITCK GMP certification, reinforcing multi‑agency compliance across drug product and mAb production.
Digitalized bioprocessing
WuXi Biologics introduced the PatroLab digital twin platform, integrating Raman PAT, mechanistic modeling, and real‑time monitoring to support QbD, predictive control, and FDA/EMA‑aligned real‑time release strategies, targeting reduced deviations and improved batch‑to‑batch consistency in biologics manufacturing.
Footprint and capacity
WuXi Biologics signed a strategic Memorandum of Understanding with the Qatar Free Zones Authority to establish a Middle East CRDMO center. Terumo completed the acquisition of the Leverkusen drug product plant. Merck began construction of a $3B Virginia facility, while Lilly announced a new Gateway Labs site in Philadelphia.
Supply chain partnerships
Sourcing moves included Brenntag’s sole distribution partnership with Seqens for non‑GMP intermediates, Croda’s strategic supply partnership with Amino for high‑purity amino acids, Evonik and Ethris to develop a novel lipid nanoparticle platform, a transatlantic ATMP manufacturing partnership, and MGC–Cirena’s long‑chain RNA in Japan.
Drug delivery advances
Evonik unveiled GMP‑grade EUDRACAP colon capsules, which later received a CPHI Excellence in Pharma award. Additional enablers included MaxiPure Polysorbate 80 for injectables and Noblyst F catalysts for flow applications; Evonik also presented the Friedrich Bergius Lecture Award to Ben Feringa.
Sustainability and market signals
WuXi Biologics reported ISO 20400 sustainable procurement certification and CDP “A” ratings, alongside a Global Customer Value Leadership Recognition. Additional signals included Lilly–IU’s clinical trial access agreement, Merck’s Q3 2025 results, and Wacker’s Q2 performance.