QbD Based Process Development Service —The DPT Labs Approach

This paper describes the approach and benefits of using DPT Labs’ QbD Process Development service and follows the second paper in our Thought Leadership Series,
“QbD Based Formulation Services – The DPT Approach.”

In that paper, we emphasized the importance of DPT’s approach to formulation, in particular the manner in which it establishes a robust baseline from which to advance the drug development process. The key components of DPT’s Formulation service – a pre-formulation study, formulation and analytical method development, and informal stability study – combine to set up a solid foundation that minimizes the risk of future unanticipated events.

Like the Formulation service, DPT Labs’ QbD Process Development service leads a customer through the steps necessary to manufacture drug product, consistently, at a scale beyond laboratory production. Beginning with a risk assessment of both raw materials and process steps, this service builds on the rigor of the formulation service and examines materials and processes to further minimize risks to development success.