
New regulatory decisions, manufacturing partnerships, and financing pressures are reshaping access, supply, and development pathways for emerging advanced therapies.
This white paper explains the benefits and challenges of microbial-based fermentation for biologics, highlighting why processes often need to be custom-built for each molecule. Outlining a streamlined, cost-effective path that accelerates development from strain selection through tox material and early GMP, to reach IND and first-in-human trials faster.






