To accelerate commercialization of biotherapeutics, organizations need to optimize processes by integrating advanced analytical tools that maximize quality, safety, and efficacy. Octet® BLI systems enable real-time, label-free analysis for the determination of kinetics, affinity, and antibody/protein quantitation. Based on Bio-Layer Interferometry (BLI), the systems enable an enviable variety of applications throughout biologics development, from early selection to validation and manufacturing. Read on to learn about the implementation in the production of biotherapeutics for titer, host cell protein analysis, residual protein detection, sialic acid content detection, potency assay development, Fab activity assay development, and more.
ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.
Beam’s base-edited cell therapy met its primary endpoint in the BEACON trial, and a U.S. biologics license application is planned as early as year-end.
Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
