Developing a vaccine that is stable at room temperature for 8 weeks - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Developing a vaccine that is stable at room temperature for 8 weeks


Pharmaceutical Technology Europe
Volume 22, Issue 1


Thinkstock Images/Getty Images
There is a pressing need to improve the storage stability of currently available vaccines, and achieving this could facilitate mass vaccination campaigns and increase vaccination coverage on a global scale — particularly to underserved and remote regions of the world. With the cost of coldchain maintenance high and its quality control difficult to ensure in developing countries, it is imperative that the stability of vaccines be improved. As such, we sought to develop a measles vaccine formulation that could be stored for a reasonable length of time at ambient temperature (25–50 C), and be transported and administered both safely and conveniently.

Following our research efforts, in collaboration with the international non-profit organization PATH, we formulated and developed an improved measles vaccine that is stable for at least 8 weeks at 37 C.1

Developing a stable formulation


The growing need for auto-injectors
Through formulation development and spray drying, we vastly improved the storage stability of the measles vaccine.


Delivering drugs through mucus
Spray drying the measles vaccine under mild conditions (i.e., low atomization pressure and drying temperature) was the key to maintaining the titre of the vaccine during processing. We utilized a nozzle that atomized the liquid vaccine into fine droplets at a relatively low pressure (compared with commercially available two-fluid nozzles) and the drying temperature was optimized accordingly; the choice of drying temperature is a fine balance between drying efficiently (i.e., at higher temperatures) and minimizing vaccine deactivation (i.e., at lower temperatures).

The stable formulations, which comprised all excipients that are approved for human use, consisted of a mixture of sugars (trehalose and sucrose) in potassium phosphate buffer as base excipients. We then incorporated our patented plasticisation technology to further enhance the storage stability of the measles vaccine. Other components that we found to stabilize the vaccine included Larginine, human serum albumin and a mixture of divalent cations.

Process challenges

The challenges we faced with the measles vaccine were the same as those encountered with other virus and bacteriabased vaccines, which we have worked on previously: to minimize the process loss; and to maintain the vaccine titre during storage.

The measles vaccine comprises live attenuated measles virus and, as such, we could not employ traditional spray drying conditions (i.e., high atomization pressure, high drying temperature, etc.); we observed process loss resulting in > 1 Log10 in vaccine titre under traditional spray drying conditions. With optimization in atomization pressure, drying temperature and solution feed rate, we minimized the process loss to < 0.2 Log10. The formulation components do have an impact on process recovery; with certain formulation mixtures, we were able to see no process loss from spray drying.


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: Pharmaceutical Technology Europe,
Click here