Newsletter | August 31, 2026

08.31.26 -- Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis

SPONSOR

 

 

Join Cell & Gene Live for "Scaling Next-Gen MSC Therapies Without Scaling Risk."  Chief Editor Erin Harris hosts CEOs from Kiji Therapeutics, Mesoblast, and MEDIPOST to explore scaling cell production without losing therapeutic efficacy. Learn practical strategies for minimizing donor variability, preserving potency, and building commercially viable platforms. Don't risk clinical success—register for free today to secure your spot!

FOCUS ON OUTSOURCING

Managing CDMO Project Risks Using Causal Mechanism & Effect Analysis

Since every sponsor–CDMO relationship can have widely different scopes, requirements, and procedures, this article focuses on the basic principles for analyzing and managing the risks of not achieving the relationship’s objectives.

 

 

Maintaining Manufacturing Continuity In Cell Therapy Development

Bridging the gap between early cell therapy development and clinical manufacturing requires operational continuity. Learn how standardizing automated equipment eliminates technology transfer friction.

 

Strengthening Lentiviral Vector Production With Platform Processes

A robust platform process can help ensure therapeutic efficacy and supply chain security for LVV-based products, as well as support aggressive development and commercialization timelines.

 

From Plasmids To Cell-Free DNA For Advanced Gene Therapies

Switching from bacterial plasmids to cell-free circular ssDNA boosts gene-editing safety and precision, reduces toxicity, enables up to 75% knock-in efficiency, and improves primary cell viability.

 

The Crucial Role Of Apheresis In Cellular Therapies

Rigorous adherence to collection protocols directly impacts patient outcomes. Listen as industry experts discuss best practices for maintaining strict quality standards during apheresis.

 

Scaling AAV Upstream Process Development To Cut Manufacturing Costs

AAV manufacturing costs can exceed $1M per dose. See how DoE in a high-throughput system cut COGs by 60% and scaled AAV9 production to 2,000 L.

 

Streamline AAV-Based Gene Therapies With Off-The-Shelf Plasmids

Standardized, well-characterized plasmids and streamlined platform processes can significantly accelerate viral vector development, improve consistency, and support scalable, high-quality gene therapy manufacturing.

OUTSOURCING SOLUTIONS

Microbial Production, Bring Pharmaceutical Solutions To Life - IDT Biologika

Market-Leading Experience Across Six Modalities - Lonza

Achieve Efficient Viral Vector Production At Any Phase - AGC Biologics

Accelerating Transformative Medicines, Small And Large - ProBio

Mitigate Risk With The Right CMO Partnership - West Pharmaceutical Services, Inc.

Fucose-Free Cell Line For Enhanced Antibody Effector Function - Lonza

iPSC Drug Discovery Platform - Applied StemCell

Streamline Every Step In Your AAV Program - 3PBIOVIAN

Connect With Cell & Gene: