The Transition from Paper Records to Electonic Batch Records

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.

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.

Merck and Kelun’s sac-TMT extends overall survival in pretreated endometrial cancer, Bristol Myers Squibb reports interim data and a patient death in its phase 1 CAR-T trial in multiple sclerosis, and BioNTech and DualityBio’s HER2 ADC meets its phase 3 goal but with limited expected benefit.

Anurag Rathore, PhD, professor of chemical engineering at IIT Delhi, explains how his team is making antibody manufacturing more efficient and replacing costly raw materials to cut monoclonal antibody costs to about $10 per gram.

Gilead agrees to acquire PepStar’s oral IL-23R peptide program for $1.275 billion, Zymeworks licenses its DLL3-targeted trispecific T-cell engager ZW209 to Roche, and the US Treasury proposes adding biotechnology to its outbound investment restrictions.