CDMO

Recent developments

Regulatory milestones

WuXi Biologics secured ANVISA GMP for MFG2, DP1 and the DPPC supporting commercial anti‑PD‑L1 supply. The Suzhou Biosafety Testing Center received its fourth EMA GMP certificate, and South Korea issued MFDS GMP certification for MFG5, DP2 and the DPPC to enable bispecific production. AGC Biologics’ Seattle facility received Anvisa GMP certification to serve Brazil.

Capacity build‑out

WuXi Biologics marked the topping‑out of its modular Drug Product facility at the Singapore CRDMO Hub to add large‑scale PFS and vial capacity by 2027. Structural completion at the Chengdu microbial commercial site advances 15,000 L fermentation with an integrated vial line. DP15 at Fengxian achieved GMP release, and AGC Biologics and Pyramid Pharma Services integrated U.S. drug substance with sterile fill‑finish.

Platform innovation

Asahi Kasei installed its FO–MD concentration system at Peptistar to intensify peptide and oligo processing without heat or pressure. Asahi Kasei Life Science licensed Noguchi Institute precision ADC technology for site‑specific single‑ or dual‑payload conjugation. WuXi Biologics launched PatroLab for digital‑twin, PAT‑enabled control, while Toray introduced a high‑efficiency separation membrane module to reduce fouling and buffer use.

Capital and restructuring

Evonik will sell selected Hanau pharma‑ingredient assets to ProChem and expand downstream bioprocessing capacity in Slovakia. The EIB provided a €125 million loan to Orano to build the ATEF, while partners financed Biovac’s end‑to‑end multi‑vaccine plant in South Africa. Amid CGT headwinds, SEQENS’ CELLforCURE initiated a sale process for its Les Ulis site.