Benefits of lyophilization and how to validate your aseptic process for lyophilized products

Berkshire Sterile Manufacturing

by Sarah Kinney



As the market moves away from small-molecule drug products and towards biologics, biosimilars, and other more complex products, the demand for lyophilization grows.

Lyophilization is the process of freeze-drying a drug product to increase its shelf life. A product that is stable in solution for only a few weeks could last for two to five years in a lyophilized cake.


There are several advantages to lyophilizing your drug product:

    • The product is processed in an aseptic environment
    • Water is removed without heat which prevents product degradation during drying
    • The shelf life of the drug product is extended, and stability is enhanced
    • Samples can be stored at room temperature indefinitely
    • The process reduces weight and volume of samples making them ideal for shipping
    • Dissolution of the reconstituted product is both easy and rapid


However, there are also several disadvantages to lyophilizing your drug product. This includes:

    • Increased handling and processing time (adds to cost and contamination risk)
    • Sterile diluent is needed upon reconstitution (adds to cost and contamination risk)
    • Extensive clean-up needed between batches (adds to cross-contamination risk)
    • Both purchasing lyophilization equipment and contracting this service this is expensive


Each drug product is unique, and there is not one lyophilization cycle that will work for all products, but proper validation can help reduce contamination risk and prevent costly repeated batches.

Lubrizol Life Science will be hosting a webinar next week on Wednesday, November 4th: Planning and Executing a Media Fill: A Guide to Aseptic Process Validation for Lyophilized Products. This webinar will explore key considerations in designing and executing aseptic process simulations for lyophilized products and it will take a deep dive into study design, operational considerations, and regulatory guidance. Their webinar will guide you in creating a robust validation that can lead to commercial manufacturing success.

Here are a few topics Lubrizol Life Science will cover:

    • The growth of aseptic lyophilization for biologics and complex drug products
    • Discuss validation requirements and regulatory guidance for aseptic manufacturing processes
    • Explain aseptic process simulation (AKA media fill) design and execution for lyophilized products
    • Investigate common challenges and solutions when performing aseptic lyophilization—including operational considerations and real-world examples
    • Understand how a well-designed validation strategy enables efficient aseptic lyophilization for the long-term

To sign up for this webinar, follow the link here.




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