PDA EU00182 Practical Guidance on Formulation Development for Lyophilized Pharmaceuticals

Lyophilization (Freeze-drying) has been used within the pharmaceutical industry for many years to improve the stability of therapies. However, developing a freeze-dried formulation that remains safe and stable and can also be freeze-dried efficiently can be difficult, requiring additional time, resources, and experience.

This course will provide an overview of how to develop a freeze-dried formulation. It will go through Quality by Design principles and how to apply this methodology to the formulation design of a wide range of freeze-dried products containing a range of active agents, including small molecules, proteins, cells, and other novel therapies. It will also review the stresses experienced during the freeze-drying process, possible degradation routes of active molecules, and how to select excipients and formulations to overcome these. The course will also provide guidance on how to determine the critical temperature of formulations and how to adjust the formulation to influence the critical temperature to make the freeze-drying process can be more efficient. And will discuss potential formulation screening methodologies, common decisions, and issues that can occur during the formulation development of freeze-dried products.

• Gain a basic understanding of the lyophilization process, together with the factors that influence the product and process.
• How to apply Quality by Design to developing a lyophilized formulation and common Critical Quality Attributes of lyophilized products.
• Understand degradation routes of products during freeze drying and the function of excipients
• Characterization to determine a product critical temperature prior to freeze-drying.
• Methodology for formulation screening and characterisation of formulations.