The Leader in Quality Life Science Training

Lyophilization and Its Application for the Pfizer Vaccine

Jan 19, 2021

As the news is inundated with stories about COVID-19, the world celebrated when the first vaccine from Pfizer was approved. 



This news was quickly followed by stories of the difficult refrigeration and distribution of the vaccine. To alleviate concerns, Pfizer announced studies into a lyophilized version of the vaccine. 


What is lyophilization? And how does this impact the future of the vaccine?


What Is Lyophilization? A Brief History and Its Modern Applications

The process of freeze-drying, or lyophilization, is a dehydration process used to preserve any product. This process begins with lowering the temperature of an item to freezing to remove water from the object while maintaining the physical and chemical structures of the original object. 


During the next step, the primary drying period, a vacuum is introduced to convert the frozen humidity into vapor through sublimation. A secondary drying period is then performed to remove any additional water molecules that were left unfrozen. An object that has been lyophilized can be reconstituted by adding water back through re-hydration. 


Removing humidity for conservation purposes has been used since at least the Egyptians and their mummification processes. In North America, the Inuit have been freeze-drying food rations for generations, using their cold, dry atmosphere. Another common preservation process is applying heat and boiling out the humidity. Re-hydration cannot return the object to its original form with any of these conservation processes. 


It wasn’t until Richard Altmann published a freeze-drying process for biological tissue in 1890 that there was a way for the original object to return to its original functionality once water was reintroduced. Further advances and new patents were soon to follow by many scientists. 

During World War II, lyophilization was used for the blood plasma and penicillin needed in the field. Prior to this, the supplies were becoming spoiled due to the lack of refrigerated transport. Using lyophilized blood plasma and penicillin reduced the number of amputations and deaths caused by infected wounds, reducing the mortality rate by 12-15%. 



In the following decades, applications for lyophilization continued to be found in food processing and pharmaceuticals. Military rations and astronaut food produced by NASA both benefited from lyophilization. The newest frontier for lyophilization is in future variations of vaccines like the Pfizer-BioNTech mRNA-based COVID-19 vaccination.


Limitations of the Current Pfizer Vaccine

In November 2020, Pfizer announced the completion of their Phase 3 study of a COVID vaccine with a success rate of more than 90%. Approval by the FDA followed in December. This was received as positive news by a world still struggling with a global pandemic, but one major difficulty in the distribution of the vaccine was quickly noted. 


The Pfizer vaccine must be kept at an incredibly cold temperature of minus 70 degrees celsius (-94°F). This creates a logistical challenge for the distribution and storage of the vaccine. According to the CDC’s vaccine playbook, they are not advising local vaccine managers to purchase specialized freezers that can handle these intense temperatures, which could hinder the widespread distribution of Pfizer’s vaccine. 


Because of this, Pfizer has created a packaging unit that keeps the vaccine at correct temperatures using dry ice, but this still leaves room for errors throughout the distribution chain from manufacturing to administration. 



The packing units can maintain the -70° C for up to 10 days unopened and up to 30 days with refills of the dry ice. Each opening creates an opportunity for error and possible ruination of a batch of vaccines. Another problem: these specialized freezers can cost up to $20,000 for each unit.


Packaging methods are another cause of concern with this vaccine. There have been a few units that have arrived at their destination in colder temperatures than specified by Pfizer. The units reached -92° C and had to be sent back to Pfizer. 


This and other concerns have limited access to the vaccine from all but the wealthiest nations and have led to Pfizer testing new variations of the vaccine for easier storage and distribution.


The Future of the Vaccine with Lyophilization

Pfizer has recently confirmed it is working on a more durable version of their vaccination, using the process of lyophilization. Freeze-drying the vaccine would make it into a powder, allowing distribution to begin sometime this year or next — based on what Pfizer’s CSO Mikael Dolsten told Business Insider


A powder form of the vaccine would be able to be reconstituted with liquid before administration. Other options would be administering the vaccine through inhalation or intranasally. Dolsten did not confirm which process of administration would be used for the lyophilized version of the Pfizer vaccine. 


There are significant benefits of the lyophilized vaccine. Storage and transportation can be conducted under standard refrigeration and not at extreme levels of freezing temperatures. This would be incredibly beneficial to regions of the world without proper storage units for the current form of the vaccine or for regions too far from distribution centers with current transport packages. 


The amount of time the vaccine can be stored will be extended by lyophilization as well, but Pfizer is too early in the testing stages to confirm an exact time frame. Hopefully, we’ll know more about the exact benefits provided by lyophilizing the Pfizer vaccine soon.


Russia is also using lyophilization to preserve and transport the vaccine they have manufactured — the Sputnik V. This will make easy the process of transporting the vaccine across Russia and its many remote settlements. They have also applied for approval in over 40 other countries. As of now, North American organizations, European organizations, and the World Health Organization have not approved the Sputnik V for administration, but this is a step in the right direction for using lyophilization on COVID-19 vaccines.


Both mRNA-based vaccines being used against COVID-19 and lyophilized vaccines, in general, are fairly new to the world market. Every progress made with these studies opens up new opportunities for future vaccinations with easy storage and transportation.


CfPIE Is Your Answer for Professional Lyophilization Training

Stay up to date when it comes to the latest on lyophilization training. Our lyophilization course provides attendees with a practical approach to understanding the scientific and engineering principles of lyophilization. This two-day lyophilization training course is designed for those in the pharmaceutical, biomedical, medical device/diagnostic, and biotechnology industries that develop and/or produce lyophilized (freeze-dried) products.


Are you interested in signing up? Click the link below to get started:


Have questions? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].


Call Us
paper_plane

Need more information on our life-science training course?

Get In Touch With Us Today!

Contact Us

Blog Categories

Transforming Skill Sets: The Role of Life Science Training Courses in Career Advancement
By The Center for Professional Innovation and Education 26 Mar, 2024
Learn how life science training courses can help you in your current job & in advancing your career. Invest in your career today with CfPIE’s life science courses.
Life Science Training Advisors Give You an Edge Over the Competition
By CfPIE 26 Mar, 2024
Achieve your career goals in life sciences industries with help from CfPIE’s life science training advisors. Save money while investing in your life sciences career
Share by: