Lyophilization considerations for research and development

By Jenny Sprung, Senior Application Specialist

On November 19, 2013 in Articles

Labconco manufactures lab-scale freeze dryers that can be used for R&D prior to a scale up process. This article outlines what you need to know before scale up can begin.

Biopharmaceuticals are routinely freeze-dried to improve product stability and, thereby, achieve acceptable commercial shelf life. However, freeze-drying is a unit operation coupled in formulation and process. While selection of excipients is primarily focused on improving product stability, for a freeze-dried product an additional consideration is the compatibility of the formulation with the freeze-drying process. The rational selection of excipients for freeze-dried product has been reviewed extensively [1-3]. This article will focus on freeze-drying process development after formulation selection. Understanding the impact of formulation and process parameters on drug product quality is critical to application of quality by design (QbD) principles, which aim to build quality within the process rather than monitoring it off-line at the end of the process. This article will lay out the approach and the significance for...

Read the entire article, "Practical Considerations for Freeze-Drying Process Design, Development and Scale-Up" by Sajal Manubhai Patel, Ph.D. et al in American Pharmaceutical Review.