04.21.26 -- All The Ways Global Biopharma Still Grapples With Annex 1

Transitioning to closed systems enables the 100-fold expansion of engineered cells. Achieve high yields and maintain anti-cancer potency while reducing contamination risks and labor.

Read how particle levels remained stable during 24 hours of high-speed mixing, even under extreme temperatures, in this mixing system for final fill and other particulate-sensitive applications.

Consider a fully automated, closed counterflow centrifuge system for your manufacturing needs. This technology streamlines the production of complex monocyte-based cell therapy workflows.

Public genomic datasets transformed cancer research, guiding assay validation and cohort design. Learn how matched biospecimens complete the loop between digital insight and biological confirmation.

Delve into freeze and thaw technology designed to prevent alterations in drug substances. These methods minimize protein aggregation to ensure stability throughout the pharmaceutical lifecycle.

Expert single-use engineers address six common questions posed by cell and gene therapy manufacturers in the design of custom single-use manifolds for the critical handling of biological fluids.

Discover how high-speed isolator lines enable sterile, scalable manufacturing for complex biologics and injectables with unmatched efficiency and product integrity.

Refining in vitro transcription (IVT) for mRNA is essential for molecular stability. These strategies enable large-scale production while maintaining the high quality required for therapies.

This presentation explores the implications of the FDA Modernization Act 2.0, the significance of predictive validity in drug discovery, the efficacy of this human Liver-Chip, and more.

Scalability remains a primary bottleneck in CGT. See how optimized stirred-tank bioreactor systems accelerate the transition from clinical R&D to full-scale commercial manufacturing phases.