Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing. Scaling up the manufacture of a ...

CDMOs within larger integrated contract service providers are well placed to provide pharmaceutical organizations with whatever support they need to complete their required process understanding, ...

Most digital twins used in biopharma are built with process data. But, while this fits with ideas like Quality by Design (QbD), it is more labor intensive than it needs to be, according to the authors ...