Download Case Study Thermostabilization of Vaccine Products

Case Study
Thermostabilization of Vaccine Products
Customer: MSD Wellcome Trust Hilleman Laboratories, India
A first-of-its-kind initiative, Hilleman Laboratories is an equal joint-venture partnership formed
between Merck & Co., a global research-driven pharmaceutical company and Wellcome Trust,
a global charitable foundation dedicated to human and animal health. Headquartered in New
Delhi, India, Hilleman Laboratories is committed to developing high impact, affordable vaccines
for people in developing countries in an innovative and sustainable manner.
Application: Thermostabilization of vaccine products
Spray drying method is used for developing vaccine formulations in stable particulate form.
Buchi B-290 is being used for thermostabilization of various vaccine candidates.
Equipment: Mini Spray Dryer B-290 and Dehumidifier B-296
Vaccine candidate/antigen in liquid form is dispersed in solvent(s) with excipients acting as
stabilizers (sugars, proteins, amino acids, polymers, surfactants, and plasticizers, as well as
charged ions) and the resultant solution is directly spray dried keeping mild to moderate process conditions. This process gives stable vaccine in powder form which can be reconstituted
with suitable buffer(s) before administration.
Benefit / Conclusion: Stable vaccine formulation in powder form
“With the spray drying technology, we have been able to achieve positive outcomes on our
flagship vaccine candidate and are planning to extend the technology to other antigens and
biopharmaceuticals as well.”
Dr. Nitin Saigal, Formulation Scientist
PH-138-13/06
Vaccines can be formulated in a stable particulate form by spray drying with acceptable aerodynamic properties. The process removes the water and restricts the biopharmaceutical’s
mobility resulting in significantly lowered degradation rate. Spray drying gives a distinct product
(in powder form) unlike the traditional lyophilized vaccines available in the market. It is a one
step process to increase the stability, temperature tolerance and shelf life of the product. The
process of spray drying makes particle engineering more feasible; by manipulating the conditions of the spray-drying process, it is possible to adjust various particle properties such as size
distribution, dispersibility, and surface enrichment of biopharmaceuticals. In addition scalability,
faster cycle time and lower operational costs gives it a distinct edge over traditional biopharmaceutical technologies.