ICH Q5A(R2) is the key regulatory guidance document for the viral safety evaluation of cell lines used in the manufacture of biologics. This guideline now specifically references Next Generation Sequencing (NGS) as an advanced virus testing tool and an ethical replacement for virus assays in animal models. In collaboration with Charles River Laboratories, Pathoquest has generated data which underscores the superiority of their GMP validated iDTECT® Transcriptome assay over MAP/HAP/RAP in the characterization of rodent cell lines. This assay harnesses the power of NGS to screen cell lines for any replicating viral contaminants and allows the replacement of two mandatory animal-based assays: in vivo adventitious virus and MAP/HAP/RAP testing.
Acuitas CEO Dr Thomas Madden and NanoVation co-founder and president Dr Dominik Witzigmann discuss how LNP engineering is expanding genetic medicine applications to traditionally undruggable targets.
AstraZeneca's sBLA for durvalumab combined with neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer, based on the Phase 3 VOLGA trial, has a PDUFA date expected in the fourth quarter of 2026.
IMVT-1402 (imeroprubart) failed to reach statistical significance on CLASI-A at Week 12 in a 57-patient proof-of-concept study, and Immunovant will stop development in cutaneous lupus erythematosus. The anti-FcRn antibody continues in five other autoimmune indications.
SOTIO Biotech's LRRC15-targeted antibody-drug conjugate SOT106 now holds both Orphan Drug and Fast Track Designations in soft tissue sarcoma and osteosarcoma. The company expects to start first-in-human testing later in 2026.
Dr Stephen Wilson, CEO of the Botnar Institute of Immune Engineering, describes Basel's collaborative ecosystem and a 3-year roadmap linking research to global clinical partners.