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.
Instead of expanding at its New Jersey headquarters, Legend Biotech opened its new R&D center in Philadelphia. This strategic move aims to attract specialized scientific talent by deliberately locating in a key innovation hub for cell therapy, demonstrating a "go to the talent" growth strategy.
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.
By partnering with Fujifilm Cellular Dynamics (FCDI), the company that developed its core technology, Kenai avoids a costly and risky tech transfer process. FCDI's existing facility can handle both clinical and future commercial scale-up, a significant operational and financial advantage.
Rather than viewing retail partners as mere buyers, Beekman 1802 treated them as strategic consultants. They actively asked for guidance on scaling production, finding labs, and co-manufacturers, leveraging the retailer's expertise and vested interest in their success.
A key driver of Legend Biotech's $2 billion revenue run rate is its successful regulatory strategy. By getting its CAR T therapy, CARVICTI, approved as a second-line treatment in both the US and Europe, the company significantly expanded its addressable patient market beyond last-resort cases.
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.
Many innovative drug designs fail because they are difficult to manufacture. LabGenius's ML platform avoids this by simultaneously optimizing for both biological function (e.g., potency) and "developability." This allows them to explore unconventional molecular designs without hitting a production wall later.
For final drug product manufacturing, Actuate engaged two separate US-based partners. This parallel track strategy provided crucial redundancy during the COVID pandemic, ensuring that a shutdown or material shortage (e.g., glass vials) at one plant wouldn't derail their clinical programs.
Ipsen avoids the high-risk, capital-intensive phase of basic research. Instead, its R&D strategy focuses on licensing promising drug candidates from universities and biotechs. The company then leverages its expertise in later-stage development, including toxicology, manufacturing scale-up (CMC), and clinical trials, to bring these de-risked assets to market.
The next decade in biotech will prioritize speed and cost, areas where Chinese companies excel. They rapidly and cheaply advance molecules to early clinical trials, attracting major pharma companies to acquire assets that they historically would have sourced from US biotechs. This is reshaping the global competitive landscape.