Volume 103 - What is Lyophilization?

Lyophilization: From Space to Pharma

Lyophilization (also abbreviated as “lyo”), the technical word for freeze drying, is a slow, low temperature dehydration process via sublimation (transition of water directly from ice to vapor) that maintains the chemical structure of the original material.

Modern day, commercial freeze drying first gained notoriety during World War II for its use creating shelf stable blood plasma and penicillin that could be used in field hospitals. It wasn’t until the 1950s and 60s that the process started being used in the pharmaceutical and food-processing industries. Among the early applications in food were freezedried meals that could be rehydrated with water and served hot to astronauts in space.

Reconstitution

Freeze-dried products are powders in their final form. Before administering the drug to the patient, the powder is reconstituted by adding a specific volume of diluent (e.g. water, saline) to the vial and inverting it as pictured below. The powder dissolves and the solution is drawn into a syringe or IV bag to dose to the patient.

Basics of Freeze Drying

Freeze Drying Lyophilization Process Diagram

Q:  Why would you spend 48-96 hours drying the water off a product at low temperature and pressure? Wouldn’t it be way easier to simply boil the water off instead?

A:  While it would be much more cost-effective to remove the water by boiling, the high temperatures harm the active ingredient (the protein) and make the product ineffective. As for the time, the process needs to happen slowly in order to preserve the crystal structure so that the product can be rehydrated.

Benefits of Freeze Drying

prescription bottle icon for extended shelf life

Extended Shelf Life

Products that are only stable for a few weeks in liquid form can be kept for two to three years after freeze-drying.

Graph icon for Less In-Process Degradation

Less In-Process Degradation

Low temperatures during manufacturing often result in less degradation compared to techniques with higher processing temperatures.

Two test tubes icon for Speed to Market

Speed to Market

Development of a lyophilization cycle is often faster/easier than developing a shelf stable liquid product.

Lyophilization Equipment

Equipment like the lyophilizers pictured below are used to perform the freeze-drying cycle depicted on the first slide. Vials are loaded onto shelves within the lyo chamber. First, the door is tightly sealed and the condenser is activated to cool the chamber. The equipment also has a strong pump that pulls air out of the chamber to create the vacuum. Lastly, during drying, the pump removes the vapor from the chamber and sends it to the condenser where it freezes.

Freeze Drying Lyophilization Equipment
ADC_CTA_Gradient2x.png

Vision.
Expertise.
Success.

Learn more about the Lyophilization and Fill Finish process.

ADC_CTA_Gradient2x.png

Sign-up for the Fun Science Fridays weekly series of insights and knowledge on the world of pharma.

Continue reading this article by subscribing to the Fun Science Fridays weekly educational series. Already subscribed? Simply enter your email below to continue.

There was a problem submitting the form. Please try again later.
required

The categories of personal information collected in this form include name, company, and contact information. The personal information collected will be used for exploratory discussions on contract manufacturing, marketing and to perform research and analytics. For more information about the categories of personal information collected by AbbVie and the purposes for which AbbVie uses personal information, visit https://privacy.abbvie.

Thank you for subscribing!

You’ve been added to our list and will hear from us soon.