A HTE + PAT Strategy for Accelerated Bio-process Development
A lack of process understanding & control leads to: inability to scale, product quality drift, & costly delays from batch failures & regulatory concerns
A lack of process understanding & control leads to: inability to scale, product quality drift, & costly delays from batch failures & regulatory concerns
Subtle changes in particle size, shape, & distribution can have a major impact on pharma solubility and stability and cause flow and formulation issues.