PDA EU00182 Practical Guidance on Formulation Development for Lyophilised Pharmaceuticals - Training / Workshop von PDA Europe gGmbH

Lyophilisation (Freeze-drying) has been used within the pharmaceutical industry for many years to improve the stability of therapies. However, developing a freeze-dried formulations which remains safe and stable which can also be freeze dried efficiently can be difficult, requiring additional time, resource, 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 formulation design of wide range of freeze-dried products containing a range of active agent, including small molecules, proteins, cells, and other novel therapies. It will also review the stresses experienced during 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 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 which can occur during formulation development of freeze-dried products.

• Gain a basic understanding of the lyophilisation process, together with the factors that influence the product and process. 
• How to apply Quality by Design to developing a lyophilised formulation and common Critical Quality Attributes of lyophilised 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.