In this technical paper, Pete Makowenskyj, Sr. Director of Design Consulting at G-CON, explains how cleanroom facilities handling hazardous materials must balance patient safety, product sterility, and operator protection. The paper outlines the regulatory landscape, highlighting gaps between contamination-control guidance and containment requirements for high-risk agents such as ADCs, radiopharmaceuticals, and spore-forming organisms. It details key design considerations—including pressure schemes, HVAC zoning, filtration, and decontamination strategies—that ensure safe, compliant operations. The paper also emphasizes the value of prefabricated cleanroom solutions for achieving tighter environments, flexibility, and future-proofing.
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.