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.

Instead of hoarding early capital, Actuate's CEO synthesized a kilogram of their molecule and sent it to labs worldwide. The goal was to fail fast by seeing if promising results could be replicated, a crucial de-risking step before committing larger funds.

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.

In Biotech, risk is removed pre-FDA approval via clinical trials, making a Chief Development Officer (clinical, regulatory, manufacturing) the most critical hire. In many MedTech sectors, risk is removed post-FDA approval via market adoption, making a Chief Commercial Officer paramount.

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.

Unlike autologous therapies where one batch treats one patient, a single batch of an allogeneic therapy can treat thousands. This scalability advantage creates a higher regulatory bar. Authorities demand exceptional robustness in the manufacturing process to ensure consistency and safety across a vast patient population, making the quality control challenge fundamentally different and more rigorous.

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.

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.

Amidst growing uncertainty at the US FDA, biotech companies are using a specific de-risking strategy: conducting early-stage clinical trials in countries like South Korea and Australia. This global approach is not just about cost but a deliberate move to get fast, reliable early clinical data to offset domestic regulatory instability and gain a strategic advantage.