The life sciences industries are going through tremendous changes that have been increased by the recent global financial challenges. In order to help pharmaceutical and biotech companies improve their operations, the FDA is promoting the use of Quality-by-Design (QbD). Much work has been done on the QbD concept of a “design space” from a manufacturing process perspective but little has been done on using QbD in formulation development including the development of formulation design spaces. Formulation studies typically involve the optimization of multiple ingredients including the API, lubricants, binders, disintegrants, etc. Such optimization can be seen as a difficult challenge when a large number of components are involved which the case is typically.
A strategy based on QbD principles that have been proven to effectively and efficiently develop useful multi-component formulations is presented in this webinar. A critical goal is the creation of formulation understanding and design space that will consistently produce a product that meets specifications with minimal risk of failure. This strategy will be described and discussed along with several examples of its use.
Areas Covered in the Session :
Approaching the development process from a strategic viewpoint, with the overall end in mind.
Designing screening experiments to identify those components that are most important to the performance of the formulation.
Designing optimization experiments to identify the optimum responses in the design space.
Analyzing both screening and optimization experiments using graphical and numerical methods.
Design space construction and associated risk analysis
Optimizing multiple criteria, such as the quality, cost, and performance of product formulations.
Designing and analyzing formulation studies that involve both formulation components and process variables using methods that reduce the required experimentation by up to 50%.
Guiding principles and tips and traps
Who Should Attend:
Executives and Managers engaged in Pharmaceutical and Biotech Research and Development
Quality Assurance Personnel
Regulatory Affairs Professionals
Test Method Development and Validation Personnel
Quality Engineers
Process and Manufacturing Engineers
Research and Development Scientists
Operations Excellence Professionals
Biologists and Microbiologists
Chemists and Chemical Engineers
Everyone who is responsible for strategizing Speeding Up Formulation Development