Newsletter | October 26, 2026

10.26.26 -- Breaking Down Development Silos In In Vivo CGT Manufacturing

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From Proof To Promise: The Future Of Genome Editing Therapeutics

Genome editing is advancing rapidly from laboratory innovation to clinical reality, but success depends on more than editing efficiency alone. Explore expert perspectives on guide RNA design, targeted delivery, off-target assessment, manufacturing scalability, quality control, and evolving regulatory expectations. Learn how these technologies and strategies are shaping the next generation of CRISPR therapeutics.

FOCUS ON OUTSOURCING

The CDMO Perspective On Breaking Down Development Silos In Vivo CGT

During this final segment of Cell & Gene Live, Solving Vector Yield Challenges in In Vivo CGT, Vishruth Gowda, an associate director on the PD team at Fujifilm Biotechnologies joins Erin Harris to discuss the manufacturing perspective.

How Real-Time Visibility Is Changing Outsourced Gene Therapy Programs

Outsourced gene therapy faces fragmented oversight. Discover how real-time operating models unify execution and risk data to drive faster, more reliable clinical delivery outcomes.

Confident Sialic Acid Identification With MS/MS

Traditional mass spectrometry left uncertainty around potentially immunogenic glycans. Learn how a biologics developer achieved regulatory-ready clarity.

Scaling Cost-Effective AAV Production For Commercial Patient Access

Balancing upstream control, downstream efficiency, and process robustness is critical for protecting the therapeutic supply chain and successfully expanding patient access at scale.

Can Synthetic DNA Replace Plasmids In Scalable Viral Vector Production?

Enzymatic DNA synthesis emerges as a plasmid alternative. Examine data on viral vector yield, quality, and purification while improving scalability and regulatory flexibility.

Critical Path For Gene Therapy: AAV Analytical Lifecycle Considerations

Explore considerations for phase-appropriate AAV characterization and release activities from pre-clinical to late-phase products. Review validation challenges and paths for maturation of analytics.

OUTSOURCING SOLUTIONS

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Bending The AAV Manufacturing Cost Curve: Scalable Platform Innovation And Productivity Gains - Lonza

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Biologics Discovery Service: From Target To Preclinical Candidates - ProBio

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Advanced Strategies For Particle Root-Cause Analysis - Coriolis Pharma

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