As the biopharmaceutical industry continues to prioritize precision and purity, material suppliers are adopting increasingly rigorous standards to combat particle contamination. Unwanted particulates in drug products, especially injectables, can lead to significant economic losses and, more importantly, pose serious risks to patient safety. Effective mitigation requires collaboration with partners who possess deep expertise in contamination control. Drawing on its heritage in the semiconductor industry, Entegris applies an exceptional level of sensitivity to purity and particle management, supported by robust quality systems, advanced contamination control technologies, and proprietary detection and sizing platforms. This paper examines the lifecycle of particle contamination in biomanufacturing and highlights practical strategies to mitigate its effects.
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.
