What to expect when commercializing fermentation-based products

The rapid growth of BioAg products has placed an unprecedented emphasis on biomanufacturing readiness. While startups often demonstrate strong lab-scale proof-of-concept, the transition to commercial production is one of the most complex and capital-intensive phases of development.

A common misconception is that fermentation scale-up is a linear extension of laboratory work. Scale-up introduces new biological, engineering, and operational variables that are not always predictable.

While limited in-house development may be appropriate early on, the true cost and complexity of scale-up infrastructure is often underestimated. Each transition represents a technical leap in oxygen transfer, mixing, heat removal, and shear forces.

Infrastructure requirements include: Steam generation, deionized water systems, high-voltage electrical capacity, and sterile consumables. For most startups, contracting these capabilities through a CDMO is more cost-efficient.

CDMO pricing is influenced by equipment time, complexity of downstream processing (DSP), labor, and microbial growth rates. Slower-growing organisms increase both costs and contamination risk.

Startups should consider engaging a CDMO when the production strain is defined and target performance metrics (CFUs, yield, titer) are estimated. A Technoeconomic Analysis (TEA) is highly recommended before committing to large-scale runs to ensure COGs are viable.

Scale-up is intertwined with compliance. Strains must be permitted under USDA APHIS where applicable, and microbial products under FIFRA require multi-batch consistency data produced at scale. These factors must be integrated into development timelines from day one.

The strongest CDMO relationships are partnerships, not transactions. Because fermentation is biology—not deterministic manufacturing—unexpected issues like contaminations can occur. Open communication and a shared understanding of risk are essential for a resilient path to market.