QbD Based Formulation Services – The DPT Labs Approach


This paper describes the approach and benefits of using DPT Labs’ QbD Formulation service and follows the previous paper in our Thought Leadership Series, “What is QbD and Why Should You Care?”

DPT Labs’ QbD Formulation service leads a customer through a rigorous process that minimizes risks to development success. Beginning with a Quality Target Product Profile (QTPP), the service further examines and narrows down formulation choices by conducting a pre-Formulation study, followed by formulation development (to include preliminary stress testing) and analytical method development, ending with an informal stability study.

DPT Labs works with customers of all shapes and sizes, from a small team and their new molecule discovery to major pharmaceutical companies. Major drug makers partner with us because they know the rigor with which we conduct Formulation development. Smaller customers leverage our vast experience and knowledge of the FDA’s expectations regarding formula, process, methods, and documentation.

Regardless of why a customer chooses DPT Labs to assist with Formulation, each one knows the first step to identifying and understanding risks in a long development process begins in Formulation. Risks that may otherwise remain hidden until much later in development can be eliminated early saving valuable time and money.