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
Tech transfer of Advanced Therapy Medicinal Products (ATMPs) presents additional challenges beyond those faced when transferring more traditional biologics.