Selecting a CMO Partner for Sterile Injectable Manufacturing

Adalvo’s purchase of Enzene’s Nplate biosimilar program extends it into biologics and moves Enzene toward a CDMO-only model.

At AAPS PharmSci 360, Thermo Fisher Scientific scientists described how predictive modeling guides technology selection for poorly soluble drugs, and outlined plans to bring solvent-free KinetiSol technology to commercial scale in 2027.

Speaking at AAPS PharmSci 360, Dr Stephanie Johnson, a principal formulation scientist at Pfizer, details how platform formulations save time before commitment, shift risk downstream, and what AI tools need to earn trust.

BMS and SystImmune’s bispecific ADC iza-bren nearly doubles progression-free survival in EGFR-mutated lung cancer, GSK and Hansoh’s B7-H3 ADC Ris-Rez extends progression-free survival in relapsed osteosarcoma, and Immatics’ TCR bispecific IMA402 posts a 32% response rate in PRAME-high tumors.

Phase 1b data at ESMO 2026 show the TCR-based T-cell engager produced durable responses in PRAME-high melanoma, with 91% of patients alive at one year in the recommended dose range.

In two small phase 1b trials, the half-life-extended bispecific antibody improved skin disease and reduced airway inflammation. Aclaris will move next into a Phase 2b trial in eosinophilic esophagitis.

Risvutatug rezetecan extended median progression-free survival to 5.5 months vs 1.4 months with chemotherapy in pretreated osteosarcoma.

Izalontamab brengitecan extended median progression-free survival to 11.1 months vs 5.7 months with chemotherapy after EGFR TKI failure.