August 7, 2017

By: douano@listlabs.com

By: Mary N. Wessling, Ph.D. ELS

 

What is Lyophilization?

Protecting the activity of enzyme products and the viability of bacterial cultures that are used in scientific experimentation is an area where List Biological Laboratories is a leader. Lyophilization has been the most extensively used technique for maintaining the integrity of biopharmaceuticals. Lyophilization (otherwise known as freeze drying) is a sublimation process: the liquids in the product go from a frozen state to a gaseous state without going through a liquid phase, leaving behind dry solids.

 

The Steps of Lyophilization

The lyophilization cycle proceeds through three steps:

1. freezing, in which the product is brought to a temperature below its freezing point at a rate that produces water crystals of ideal size;
2. primary drying, during which the crystals undergo sublimation under vacuum;
3. secondary drying, which removes residual water vapor after the primary drying. Finally, the lyophilized product may be sealed in an inert gas atmosphere.¹

 

Why Lyophilization is Important

Lyophilized formulations of biopharmaceuticals must be approached based on the specific vulnerability of the original product. List Labs is very experienced in producing lyophilized products; most of our stock products and many of the products produced through our GMP Contract Manufacturing services are lyophilized. To ensure activity and viability, List Labs evaluates the use of various sugars, proteins, small molecules, polymers, and salts in candidate formulations. Also, the products can be aliquoted into vials and lyophilized, which makes for increased efficiency of use and preserves the integrity of the product when used in experimental studies over some time. The demands for quality and safety of biological products, such as vaccines, are very stringent;² the FDA document regarding lyophilization of parenterals provides a useful overview of the lyophilization process from a regulatory point of view. List Labs’ lyophilized products have been used in a wide range of experimental procedures for more than thirty years.

References

1. Chang BS, Reilly M, Chang H. Lyophilized Biologics. In: Varshney D, Singh M, eds. Lyophilized Biologics and Vaccines. New York: Springer; 2015:93-119.
2. Bloom BR, Lambert P-H, eds. The Vaccine Book. 2 ed. Amsterdam, Boston: Elsevier Academic Press; 2016:90-92. PMCID: PMC3323310