Massimo Morbidelli

On the Use of Hybrid Models and Latin Hypercube Sampling to Develop a Chemically Defined Culture Medium Formulation for pDNA Production in E. coli

The demand for pharmaceutical-grade plasmid DNA (pDNA) is projected to outpace current manufacturing capacity due to the expanding clinical pipeline of Advanced Therapy Medicinal Products (ATMPs). While regulatory bodies (FDA, EMA) advise against complex media in an evolving regu...