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

In that paper, we emphasized the importance of DPT’s approach to process development, in particular the rigorous analysis of both raw materials and process steps from which to advance the drug product development process. The key components of DPT’s Process Development service – a risk assessment and feasibility batches – combine to lay a solid foundation that minimizes the risk of future unanticipated events.

Like the Process Development service, DPT Labs’ QbD Scale Up service leads a customer through the steps necessary to manufacture drug product, consistently, at commercial scale. Leveraging the rigor of determining both raw materials and process steps in the Process Development service, the Scale Up service meticulously determines and documents the transition from clinical scale production to commercial scale production.

If a customer worked with us during the process development stage, it is an easy transition to the QbD Scale Up service. Some customers, however, come to us for the first time at this point in the drug development process. In either case, DPT provides a dedicated, experienced, and talented group of scientists, state-ofthe- art equipment and facilities in which to perform the work necessary to prepare the drug product for commercial scale production. The goal is the same – to produce drug product in a reliable, consistent, and repeatable way. Simply finding a stable formulation is only the first step in a development process. Building a documented capability to manufacture drug product the same way, every time, is a critical step on the road to approval. We work with major pharmaceutical companies as well as smaller drug development customers – and both benefit from our vast experience and knowledge of the FDA’s expectations regarding process, methods, and documentation.