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White Papers / Tech Papers

QbD BASED PROCESS DEVELOPMENT SERVICE — THE DPT LABS APPROACH

Released By DPT

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.

If a customer worked with us during the formulation stage, it is an easy transition to the QbD Process Development service. Some customers, however, come to us for the first time at this critical point in the drug development process. In either case, DPT provides a dedicated, experienced, and talented group of scientists, state-of-the-art equipment and facilities in which to perform the work necessary to prepare the drug product for clinical 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.

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