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| |  To maintain stability and viability, most childhood vaccines must be kept cool – both heat and freezing can ruin them. That means many must be refrigerated at the correct temperature throughout transportation, storage, and delivery. This cold chain is difficult and costly to maintain, especially in developing countries. Dr. Gardner and his colleagues are adapting high-throughput formulation technology developed by TransForm Pharmaceuticals, Inc. that can quickly screen different formulations of vaccines to identify those that are most likely to be stable, safe, and effective. The team's initial work focuses on reducing refrigeration requirements for the existing live attenuated vaccine for measles, a freeze-dried vaccine that must be stored at between 2° and 8° Celsius and is very sensitive to heat and light once it is reconstituted. The project team is evaluating a large and diverse set of solution formulations and freeze-dried preparations for physical stability and biological activity.
The next stage of the project involves bringing all elements together to allow high-throughput screening of novel formulations, which investigators hope will have significantly improved thermostability over the commercial measles vaccine, both in the solution and the lyophilized states. This work will be underpinned by back validation experiments using non-recombinant viruses. Investigators expect to test the general applicability of the methodology to other vaccines and select an additional vaccine for formulation or reformulation. |
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| | | Design, build, and validate a high-throughput (HT) platform for the vaccine application | | | | | Apply the platform towards improving stability of the measles strain(s) used in the commercial vaccines | | | | | Test the general applicability of the methodology and improve one additional vaccine | | |
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| | | Refined the measles virus (MV) bioassay, which had been developed to measure virus infectivity. | | | | | Executed the semi-automated process, which had been designed to test measles virus infectivity in a large number of different formulations. | | | | | Outlining an equivalent automated process for virus lyophilisation, reconstitution, and infectivity assessment. | | | | Designed and built the high-throughput platform for solution-based vaccine formulations. | | |
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| | | Dr. Paul Duprex , TransForm Pharmaceuticals, Inc., Massachusetts, United States - US | | |
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