Newsletter | August 28, 2026

08.28.26 -- OPCU: Scaling Your Program Without Creating New CDMO Risks

 

 

As biologics programs advance toward commercialization, cell line development and manufacturing decisions are being made earlier and with far less room for error. What may seem like manageable challenges during early clone selection and development can surface later as product variability, cell line instability, technology transfer complications, and scalability limitations that threaten clinical timelines and commercial readiness.

 

Successfully navigating these complexities requires a clear understanding of how cell line development, 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 biologics CDMOs are helping sponsors establish stable, high-producing cell lines, 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

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.

CELL LINE DEVELOPMENT

Abzena

Move from sequence to clinical manufacturing with fewer bottlenecks and less risk. Explore the complete technical presentation to see how a smarter developability strategy can accelerate your path to the clinic.

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Abzena

Lonza

This discussion covers our new GS Ori-Go™ vector technology, which delivers outstanding titers and stability across our mammalian platform, while enabling streamlined CLD processes and faster DNA-to-IND timelines in as little as six months.

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Lonza