The silkworm platform changes the manufacturing paradigm from "scaling up" to "scaling out." Instead of building larger, more expensive bioreactors, production is increased simply by using more pupae. This model offers greater flexibility to adapt to demand, lowers infrastructure costs, and reduces the engineering risks associated with traditional scale-up.
Founders are breaking down complex societal challenges like construction and energy into modular, repeatable parts. This "factory-first mindset" uses AI and autonomy to apply assembly line logic to industries far beyond traditional manufacturing, reframing the factory as a problem-solving methodology.
The combination of AI reasoning and robotic labs could create a new model for biotech entrepreneurship. It enables individual scientists with strong ideas to test hypotheses and generate data without raising millions for a physical lab and staff, much like cloud computing lowered the barrier for software startups.
Atomic Industries is scaling its manufacturing operations by creating a bifurcated factory system. Its first facility is dedicated solely to designing and creating molds. These molds are then shipped to a second, larger facility focused exclusively on high-volume part production, optimizing the workflow for both complex tooling and mass manufacturing.
To ensure pharmaceutical-grade consistency from a living organism, Kaiko addresses biological variability with stringent controls. This includes using Specific Pathogen-Free (SPF) grade pupae from specialized facilities and collaborating directly with regulatory bodies like Japan's PMDA to establish clear acceptance criteria, aligning the novel platform with pharmaceutical expectations.
As a company grows, its old operational systems and processes ('plumbing') become obsolete. True scaling is not about addition; it's about reinvention. This involves systematically removing outdated processes designed for a smaller scale and replacing them entirely.
Contrary to the belief that living organisms are too variable for biomanufacturing, Kaiko's work shows that silkworms can be powerful and consistent bioreactors. With the right controls, this platform produces pharmaceutical-grade proteins, including vaccine antigens, meeting modern regulatory expectations and creating new manufacturing possibilities.
Instead of buying expensive, custom-built lab equipment, Shelter Skin creatively repurposed machinery from the food and beverage industry, like bakery mixers and milk pasteurizers. This resourceful approach enabled them to scale production on a bootstrapped budget, proving ingenuity can replace capital.
Unlike most biotechs that start with researchers, CRISPR prioritized hiring manufacturing and process development experts early. This 'backwards' approach was crucial for solving the challenge of scaling cell editing from lab to GMP, which they identified as a primary risk.
Business growth isn't linear. Scaling up introduces novel challenges in complexity, cost, and logistics that were non-existent at a smaller size. For example, doubling manufacturing capacity creates new shipping and specialized hiring problems that leadership must anticipate and solve.
According to a published comparative study, a single silkworm pupa can produce the equivalent amount of recombinant protein as approximately 120 mL of SF9 insect cell culture. This high-density output creates massive economic and footprint advantages by eliminating the need for large bioreactors, sterilized media, and extensive cleaning validation.