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DelSite Working Toward Solving Delivery of Influenza Vaccine in Pandemic Situations

e U.S. for production of vaccine antigens. This egg-based manufacturing process requires a minimum of six months. The newest technology available uses a mammalian cell line to produce antigens. This cell-based technology is more efficient, faster, and eliminates allergic problems caused by egg proteins.

DelSite's GelVac(TM) powder vaccine technology works with egg- or cell-based antigen. In addition, the use of a whole virus (whole virion) provides more potent vaccines than vaccines produced using split or partial parts of the virus; the GelVac(TM) technology may be used to deliver vaccines made from any of these methods.

DelSite's GelVac(TM) platform is based on the GelSite(R) polymer, a negatively-charged linear polymer with a molecular weight greater than 450,000 which is derived from a natural source and is classified as a GRAS (generally regarded as safe) by the FDA.

GelSite(R) is produced in kilogram quantities under FDA good manufacturing practices for human drugs (cGMP) in an ISO-certified facility. Each kilogram of the GelSite(R) polymer can be used to manufacture approximately 5 to 8 million vaccine doses. Plant material used in the production of GelSite(R) polymer is recognized as certified organic by the U.S. Department of Agriculture, European Union and government of Costa Rica.

After the Influenza Conference concluded, Dr. Yawei Ni, chief scientific officer of DelSite, stated, "Our GelVac(TM) powder vaccine delivery platform was the only powder system at the conference, and I believe it can be used to solve or alleviate basic technology problems that would be created by a worldwide pandemic. We have completed the Phase I safety study for the powder system and will file an IND with the FDA for a Phase I clinical study using a H5N1 antigen later this year."


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