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.

Instead of viewing a pilot plant as just an R&D cost center, design it to be profitable. This self-sustaining model provides commercial validation and helps secure pre-sale agreements, which can then be leveraged to finance a full-scale industrial facility with less investor risk.

The use of low-cost, scalable plastic tank bioreactors eliminates the need for traditional, expensive GMP facilities. This allows companies to convert cheap, underutilized office space into production labs, enabling a novel business model of decentralized, onshore manufacturing that dramatically lowers real estate and operational costs.

Unlike traditional fermentation where moving to larger tanks introduces significant process variability, photosynthetic systems using photobioreactors scale modularly. Companies can simply add more units ("scaling out"), which minimizes performance differences and de-risks the transition to commercial-scale manufacturing.

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.

In a highly technical field like radiopharmaceuticals, success requires combining distinct capabilities. Crown Bioscience's partnership with Medicine Discovery Catapult merges preclinical modeling expertise with radiolabeling know-how, creating a comprehensive service offering that would be difficult for one organization to build alone.

CEO Marc Salzberg clarifies that for their recombinant protein, the difficulty was not in the manufacturing itself but in designing the complex upstream process, purification, and analytics. This innovation became a core asset and "claim to fame," allowing them to transfer a well-defined process to a capable CDMO for scaling.

Existing agricultural giants have no incentive to process small batches of novel crops for startups. To prove market demand and achieve scale, innovators must acquire their own processing capacity, a risky but essential move to get products to market.

To overcome production bottlenecks, Legend Biotech employs a diversified manufacturing strategy. They operate their own large facilities in the US and Belgium while also contracting with pharmaceutical giant Novartis to produce their CAR T therapy. This enables a rapid scale-up to a planned 10,000 annual doses.