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news.Invitrogen Corporation has come to an agreement to develop a scalable manufacturing process to incorporate a bird flu antigen into DelSite Biotechnologies' nasal vaccine product.
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DelSite is developing a nasal powder vaccine for pandemic avian influenza that combines its proprietary GelVac vaccine delivery system with an avian H5 influenza whole virion antigen.
Preclinical studies were initiated in December 2004 under a $6 million, 3-year biodefense grant, and formulation development has been ongoing using antigen produced at laboratory scale.
The agreement with Invitrogen will allow DelSite to move from the current lab scale procedures to a scalable manufacturing process in advance of initiating production for clinical trials.
In 2005, the Company completed a phase I clinical trial of the GelVac delivery system, without antigen, that demonstrated that GelVac is safe and well tolerated and that doses were consistently and reproducibly delivered to the nasal cavity.
“We are very pleased to be working with Invitrogen in the development of our whole virion influenza vaccine,” said Dr Kenneth Yates, president of DelSite. “Invitrogen’s experience in developing GMP manufacturing processes will accelerate the clinical development of our avian flu vaccine.”