Newsletter | August 19, 2026

08.19.26 -- OPCU: Capabilities For Choosing The Right CDMO For Gene Therapy Success

 

 

As gene therapy programs advance toward commercialization, development and manufacturing decisions are being made earlier and with far less room for error. What may seem like manageable challenges during development can surface later as product variability, technology transfer complications, supply chain constraints, and scalability limitations that threaten clinical timelines and commercial readiness.

 

Successfully navigating these complexities requires a clear understanding of how process development, GMP manufacturing, scale-up, and CDMO strategy work together throughout the product lifecycle. In this edition of the Outsourced Pharma Capabilities Update (OPCU), explore how leading cell and gene therapy CDMOs are helping sponsors reduce downstream risk, simplify technology transfer, and build manufacturing strategies that support long-term success. Watch the presentations below to learn how different development and outsourcing approaches can impact program outcomes from early development through launch.

 

Recent Sessions Available On-Demand              
Cell Therapy & Cell Line Development – July 2026          
ADCs And Microbial Development & Manufacturing – July 2026     

 

Upcoming OPCU Topics & Times

CPHI Special Edition | 8/27/2026, AM Session            
Fill/Finish | 9/1/2026, AM Session            
ADCs | 9/11/2026, AM Session            
AI Innovation in Drug Development & Manufacturing | 9/29/2026, AM Session            
Viral Vectors | 9/29/2026, PM Session            
mRNA | 9/30/2026, AM Session            
Packaging, Labeling, & Logistics Services | 9/30/2026, PM Session            

 

Access more on-demand OPCU recordings and upcoming sessions here.

GENE THERAPY

SK Pharmteco

Adaptive viral vector platforms pair scalable manufacturing with targeted purification. Customizing workflows ensures high vector purity and cost efficiency, accelerating clinical development.

Request Information

SK pharmteco

Andelyn Biosciences

Modular vector platforms blend custom transfection with gentle purification. Optimized TFF plus precise chromatography yield high vector recovery across diverse cell and gene therapy applications.

Request Information

Andelyn Biosciences

FUJIFILM Biotechnologies

From process development to GMP manufacturing, our teams operate as one connected system to support your cell or gene therapy through every milestone.

Request Information

FUJIFILM Biotechnologies