Biologic medicines have transformed modern healthcare, enabling treatments for cancer, autoimmune disorders, and rare diseases that were previously considered untreatable. Yet many promising biologic therapies never reach patients, not because of biology, but because they cannot be manufactured at the needed scale, quality, or cost.

As therapeutic modalities become increasingly complex, including multispecific antibodies, fusion proteins, gene therapies, and AI-designed proteins, manufacturing bottlenecks are becoming a central challenge in drug development.

During this talk, we explain why the secretory pathway is one of the most critical but under-engineered constraints in biologics production. We demonstrate the first high throughput strategy for analyzing and engineering signal peptides, short amino acid sequences that direct proteins into this pathway, and their fundamental role in determining production yield and quality for antibodies, vaccines, and other high-value biologic therapeutics that depend on efficient, scalable manufacturing.