Kaiko uses a phased regulatory approach, starting with faster-to-market animal products like functional feed additives in Vietnam. This strategy validates their technology and generates revenue while navigating the longer, more complex regulatory pathways for human pharmaceuticals.
Unlike plant-based systems that suffer from low protein expression and high scaling costs, silkworm pupae function as dense, natural bioreactors. This allows for high-yield production at a low cost, making oral vaccines commercially viable where previous attempts have failed.
Silkworm biomanufacturing offers incredible production density, with one pupa producing 10-20 mg of protein. Scaling requires simply adding more pupae ('scaling out') rather than building larger facilities ('scaling up'), enabling decentralized, small-footprint manufacturing.
Reaching Phase 1 trials represents a monumental regulatory achievement. It signifies that Kaiko successfully established a novel quality control, raw material, and CMC framework with regulators for an unprecedented manufacturing platform, opening the door for all future products.