11.10.26 -- Your CDMO Quality Dashboard Is Green. What's It Hiding?

Watch as our CGT experts explore the evolving landscape of viral vector manufacturing, overcoming production bottlenecks, and the strategies necessary to bring life-changing therapies to more patients.

Audit-ready cryopreservation workflows reduce risk, protect biological integrity, and support compliant scaling from research through commercialization.

Outsourced gene therapy programs suffer from fragmented, lagging visibility across CDMO networks, and a real-time integrated operating model unifies execution, governance, and risk data.

Explore how starting material decisions affect cell therapy development, tech transfer, and GMP readiness, as well as practical guidance for aligning material requirements.

By integrating perfusion into upstream manufacturing, see how this approach has achieved up to a fivefold increase in productivity, delivering titers that significantly exceed current industry benchmarks.

Digital CMC platforms address tech transfer inefficiencies by unifying process knowledge, reducing compliance risk, and significantly compressing CDMO onboarding timelines.

Discover how an autologous CAR-T platform is addressing challenges in cell therapy manufacturing. A three-day process shortens cycles, improves T-cell potency and durability, and reduces costs.

Assimilate how the iCELLis500+ fixed-bed bioreactor supports the scalable manufacturing of both AAV and oncolytic virus therapies, detailing successful process development and scale-up strategies.

FDA CRLs reveal how insufficient stability data, weak CMC strategies, and product quality concerns can delay approvals, underscoring the need for robust stability programs.

CRISPR's potential depends on more than biology. Learn how advances in delivery, safety, manufacturing, and regulation are enabling clinical translation at scale.

A structured, phase-appropriate regulatory roadmap helps cell therapy developers reduce risk, streamline manufacturing and testing, and avoid costly clinical delays.

NGS transcriptome methods offer a sensitive, animal-free alternative for detecting viruses in cell banks. Analyzing total mRNA transcripts enables precise identification and regulatory compliance.