Scale Decisions for MSC Manufacturing: Build In-house or Partner with a CDMO

The decision to build in-house or partner with a CDMO is less philosophical than it appears. At its core, it is a question of where manufacturing risk will live over the next 24 to 48 months.  Most teams believe they are choosing a manufacturing location. In reality, they are choosing how much operational, regulatory, and execution risk their organization can absorb while advancing the clinical program. 

When Building In-house Is Rational 

In-house manufacturing can make sense when: 

• The MSC process is already stable and well-characterized
• There is a clear commercial strategy that justifies capital investment
• GMP operators, quality leadership, and technical staff can be recruited and retained 
• The organization can absorb the cost of future process changes and comparability work 

The limiting factor is rarely scientific talent. It is the presence of a functioning quality system, validated aseptic behaviors, and sustained operational discipline. 

When Partnering Is Rational 

Partnering often wins when: 

• Speed to clinic outweighs facility ownership
• The process is still evolving and requires experienced process development support
• Access to closed or semi-closed platforms is needed without long lead times
• Integrated QC testing and stability programs are required from the start
• An inspection-ready GMP facility is needed immediately
• The need for flexible capacity and ability to rapidly scale from clinical to commercial manufacturing   

The Hybrid Option Many Teams Overlook 

A third option exists: hybrid client-in-plant models that preserve internal oversight while leveraging an established GMP environment. 

For many programs, this approach provides a practical bridge between early outsourcing and long-term internal manufacturing without assuming full facility risk upfront. 

A Decision Framework Holds Under Pressure 

1. Patient delivery risk 
   If reliable product delivery is at risk, process optimization becomes mandatory regardless of who manufactures. 
2. Comparability exposure 
   Early, phase-appropriate optimization reduces future regulatory and comparability burden. 
3. Capability fit 
   Ensure alignment between process needs and available platforms, particularly for harvest, wash, formulation, and fill & finish. 
4. Operating model realism 
   Assess whether the team can truly operate GMP manufacturing while advancing clinical research and fundraising. Many early-stage organizations cannot, and that constraint is structural, not a failure of ambition.