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.

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.

Transitioning a biotech from discovery to development is not just a scientific step but a cultural one. According to Ron Cooper, it requires moving from a flexible "innovation and ideation culture" to a rigorous "engineering culture" focused on process and precision in areas like clinical trials and large-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.

Resolution Therapeutics' CEO warns that manufacturing process changes cannot wait for pivotal trials in cell therapy. The drug product used in a Phase 1/2 study must be highly comparable to the final commercial version to avoid extremely costly delays and extensive comparability studies later in development.

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.

Scaling complex cell therapies follows a similar trajectory to monoclonal antibodies. The strategy involves establishing a global footprint with regional manufacturing facilities (e.g., US West, US East, Europe) to serve distinct geographic areas. This approach ensures manageable logistics and reliable delivery for personalized medicines, leveraging historical lessons.

The immense capital investment needed to build global manufacturing and commercial infrastructure makes it nearly impossible for most startup or mid-stage cell therapy companies to scale independently. According to Kite's Cindy Perettie, partnering with a large pharmaceutical company is a practical necessity for reaching global markets.