Real-world examples of how integrated workflows drive faster CGT readiness
As the demand for pivotal clinical milestones increases, biopharma leaders face rising pressure to accelerate IND timelines without sacrificing quality, compliance, or scalability. For this, CGT organizations that strategically align manufacturing, analytics, trainings, and regulatory readiness are better positioned to advance efficiently towards clinical and commercial success.
This curated set of real-world case studies demonstrate how integrated CGT platforms reduce risk, strengthen regulatory positioning, and enable resilient progress from early development through clinical execution. As the demand for pivotal clinical milestones increases, biopharma leaders face rising pressure to accelerate IND timelines and late-phase clinical development without sacrificing quality, compliance, or scalability.
Unlocking CGT performance: proven strategies for modern operations
Case study booklet: View three examples of how advanced CGT programs prepared for IND and late‑phase trials by integrating manufacturing, analytics, and GMP training, showing how automation cuts risk, improves data readiness, and speeds timelines.
Automated clinical-grade manufacturing of Vγ9Vδ2 T cells on the CliniMACS Prodigy®
White paper: How a closed-system workflow streamlined the manufacturing of Vγ9Vδ2 T cells to achieve clinically relevant doses for adoptive cell therapy. Viral transduction using BaEV lentiviral particles directly in the processing workflow efficiently generated CAR γδ T cells within the same automated process, demonstrating a robust and scalable approach to advanced cell therapy manufacturing.
DownloadImproved sensitivity in flow cytometry by in-line pre-enrichment of CAR T cells and antigen-specific T cells on the MACSQuant® Analyzer
White paper: See how combining in-line pre-enrichment with advanced flow cytometry dramatically increased detection sensitivity for rare CAR T and antigen-specific T cells. Implementation of enhanced analytical workflows strengthened data quality, increased regulatory confidence, and established a more robust foundation for commercial-ready development.
DownloadAutomated tumor-infiltrating lymphocyte expansion on a GMP-compliant cell manufacturing platform
White paper: GMP-compliant automated tumor-infiltrating lymphocyte (TIL) expansion enabled standardized, scalable manufacturing with high reproducibility and process control. Fully functional tumor-reactive TILs were successfully generated from ovarian cancer tissues and expanded through an automated, scalable workflow, demonstrating a robust and consistent approach to advanced cell therapy production and clinical readiness.
DownloadAchieving inspection-readiness for cell sorters and analyzers
Webinar: Learn how standardization, electronic documentation, workflow segregation, and digital traceability reduce risk, improve compliance, and prepare CGT operations for regulatory inspection success.
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