Partner
Arecor have been working with the
Program for Appropriate Technology in Healthcare (PATH), which is based in Seattle, WA, USA on the development of heat stable aqueous formulation of the Hepatitis B vaccine. This project is part of a program to expand the coverage of hepatitis vaccination in developing countries.
Problem
Vaccines, in particular the Hepatitis B presented to Arecor are susceptible to loss of antigenic activity at temperature above 2-8°C rendering them ineffective. This necessitates the maintenance of a cold-chain which is not always possible in developing countries.
Strategy
Arecor applied Arestat T™ technology to stabilize the recombinant Hepatitis B vaccine
Results
• The Arestat-enhanced vaccine was demonstrated to be stable at temperature up to 55ºC but for practical applications, best stability was observed at 37ºC. Antigenic activity was maintained for 12 months at 37ºC providing sufficient justification for it to be adopted as a clinical candidate.
• The integrity of the vaccine has been confirmed by a range of in vitro and in vivo analytical methods.
• The vaccine has completed pre-clinical studies and is being progressed into clinical development.