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.
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.
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.
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.