Analytical techniques are essential to ensuring the quality, efficacy, and safety of biopharmaceutical products. Advances in instruments and methods are providing biopharmaceutical drug developers, process and manufacturing managers, and quality teams with the capabilities to identify potential problem areas quickly and effectively, and to expedite drug production.
In this eBook, the editors share the new technologies and methodologies to analyze and characterize monoclonal antibodies, protein therapeutics, and emerging therapies, as well as best practices to ensure the integrity of analytical test data and evaluate cleaning validation efforts.
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.
FDA expands Winrevair’s label with HYPERION data, formalizes the use of non-animal testing methods, and Amgen reports positive Phase 3 results for dazodalibep in Sjögren disease.
The FDA has approved a label update for Merck's Winrevair (sotatercept-csrk) incorporating Phase 3 HYPERION data, showing a 76% reduction in clinical worsening events when added to background therapy in adults diagnosed with pulmonary arterial hypertension within the past year.
