This webinar will cover the basics of lyophilization, Container Closure System considerations for lyophilized drug products, and factors influencing lyophilization performance and drug moisture content.
Lyophilization is the process of dehydrating a material at low temperature and reduced pressure (i.e., freeze drying). It is used to extend the shelf life of drug products, especially biologics. Through 2019, the United States Food and Drug Administration had approved over 400 drug products in lyophilized form with over 90% being delivered in single-use vials. The container system is crucial in maintaining the stability and integrity of the lyophilized product through its shelf life. The components in the container system must be carefully selected to ensure no adverse interaction with the drug product, reduce risk for potential of moisture migration and be suitable for the lyophilization process.
The basics of lyophilization and the various stages during a lyophilization process will be discussed. The factors influencing lyophilization performance will also be covered. We will address some of the common questions pharmaceutical manufacturers may have when selecting the packaging components to be used for a lyophilized drug.
Moisture control is a key aspect for lyophilized drug products. We will go through how to control and measure the residual moisture content in stoppers and the factors influencing the moisture content in the stopper and drug product over time. Container closure integrity will be one of the discussion points.
Register now and join us in the webinar to get a better understanding of the lyophilization process and key considerations for selection of packaging components for lyophilized drugs.
Key Learning Objectives
- Understanding the basics of lyophilization process and factors influencing lyophilization performance
- Factors influencing moisture content in stopper and drug and how to better control and mitigate risk
- Addressing common questions faced when selecting packaging components for lyophilized drugs
