Sana CEO Steve Harr actively questions whether the company's groundbreaking science can translate into a scalable, commercially viable therapy. This internal pressure focuses the team on solving not just the scientific challenges ("does it work?"), but also manufacturing ("can you scale it?") and the commercial model required for a true cure.

The focus in advanced therapies has shifted dramatically. While earlier years were about proving clinical and technological efficacy, the current risk-averse funding climate has forced the sector to prioritize commercial viability, scalability, and the industrialization of manufacturing processes to ensure long-term sustainability.

Contrary to the popular belief that antibody development is a bespoke craft, modern methods enable a reproducible, systematic engineering process. This allows for predictable creation of antibodies with specific properties, such as matching affinity for human and animal targets, a feat once considered a "flight of fancy."

By training on multi-scale data from lab, pilot, and production runs, AI can predict how parameters like mixing and oxygen transfer will change at larger volumes. This enables teams to proactively adjust processes, moving from 'hoping' a process scales to 'knowing' it will.

A significant portion of biotech's high costs stems from its "artisanal" nature, where each company develops bespoke digital workflows and data structures. This inefficiency arises because startups are often structured for acquisition after a single clinical success, not for long-term, scalable operations.

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.

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.

Airway Therapeutics' CEO founded a CRO to resolve the disconnect between academic research's discovery focus and industry's market-driven goals. This "translator" model aligned incentives and regulatory understanding, fostering more efficient drug development by merging clinical feasibility with commercial targets.