Biotech Startup Successfully Scales mRNA Manufacturing

Biotech Startup Successfully Scales mRNA Manufacturing

Background

A small biotech company with a promising mRNA therapeutic needed to rapidly scale from research quantities to commercial manufacturing.

The Challenge

• Lab-scale process producing only milligrams
• Need to reach kilogram-scale within 18 months
• Limited internal manufacturing expertise

The Solution

CDMO Selection Process

The company used a structured evaluation to select a CDMO partner with:

• Existing mRNA manufacturing capabilities
• Regulatory track record with novel modalities
• Flexible capacity and scale-up expertise

Results

• Achieved commercial scale in 14 months
• 95% batch success rate at scale
• Regulatory approval in multiple markets
• Cost reduction of 60% vs. in-house projections

Key Learnings

1. Early CDMO engagement accelerates timelines
2. Joint team structure improves communication
3. Flexible contract terms enable rapid scaling