Integrating capabilities like machining isn't just a cost-saver. For startups, it's a strategic advantage that grants direct control over the development lifecycle, enabling rapid iteration and faster time-to-market by eliminating vendor dependencies.

Contrary to the decade-long trend of outsourcing to CDMOs, major pharmaceutical companies are now vertically re-integrating their supply chains. Driven by supply chain vulnerabilities, they now view manufacturing not as a cost center but as a strategic advantage, creating opportunities for technology enablers rather than just capacity providers.

Unlike small-molecule drugs, biologics manufacturing cannot be simply scaled up on demand because "the process is the product." A superior manufacturing and supply chain capability is not a back-office function but a key market differentiator that commercial teams must leverage to win customers and outpace competitors.

Counter to the lean biotech model, Vivtex avoids outsourcing to CROs. The rationale is that only an internal team, whose survival depends on the technology's success, possesses the existential urgency to solve problems at the breakneck pace required—a speed external partners cannot match.

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.

For hard tech startups, the decision to vertically integrate and build a factory shouldn't be automatic. It's a strategic imperative only when "cadence"—the speed of iteration and delivery—is the primary competitive advantage. In such cases, the in-house capability to move fast outweighs the high capital cost.

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.

Companies, especially in early stages, should resist outsourcing production too quickly. Keeping a new process in-house is essential for understanding its pain points, which is a prerequisite for being able to specify clear, effective requirements to an external vendor later on.

A company's development approach is dictated by its business model. Startups use simple, low-cost methods for quick proof-of-concept data. Large pharma invests in robust, high-throughput systems to de-risk processes for regulatory demands. CDMOs must be flexible to serve both.