QbD Based Formulation Development – The DPT Labs Approach

DPT Labs’ QbD Formulation Development 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 through a strategic process involving pre-formulation and preliminary stress testing activities, prototype formulation development, analytical method development, and informal stability testing.

DPT Labs works with customers of all shapes and sizes, from a small team of scientists 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 evaluation and testing. Smaller customers leverage our vast experience and knowledge of the FDA’s expectations regarding ingredients, process, methods, and documentation.

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

Join Michael Lowenborg in this short 30 minute webinar as he discusses DPT’s approach to QbD based formulation development services:

  • QbD – Why should you care?
  • Pre-Formulation Studies
  • Formulation Development Methodologies
  • Informal Stability Testing
  • Analysis and Interpretation of Study Results
  • Benefits of QbD Based Formulation Services

- Download Webinar (MP4, 19 MB)