New manufacturing process can double HIV vaccine production
cell culture medium that can double viral antigen yields in HIV
vaccine development.
The company believes its economically viable and reproducible manufacturing process will pave the way for the production of large quantities of a vaccine to fight this killer disease.
The IRC said it collaborated with US biotech firm Irvine Scientific to develop a serum-free cell culture medium for the HIV vaccine production process that eliminates all animal-derived components and thus the risk of prion and microbe contamination, improves viral yield, and provides consistently high cell growth through to full-scale production.
Through a process of screening and optimisation, the two firms have demonstrated that the human T-cell lymphoma cell line HUT-78 (chronically infected with HIV-1) can be grown and reliably passaged in a chemically-defined cell culture medium, with cell densities exceeding two million cells/ml and a two-fold improvement in initial HIV-1 viral antigen yields over traditional serum-supplemented medium.
The IRC presented evidence of this at the recent Vaccine Technology Conference, held in Puerto Vallarta, Mexico.
"The development of this medium is an important step in the development of a vaccine utilising whole-inactivated HIV to stimulate the human immune system against the virus," said Peter Lowry, IRC vice president of manufacturing operations.
"This new serum-free medium greatly enhances our ongoing efforts toward an efficient, economically viable, and reproducible manufacturing process that will allow us to produce safe and consistent whole-inactivated viral vaccines in large quantities."
The IRC said it now plans to use this technology towards the development of a preventive HIV vaccine and is also currently evaluating this approach for a therapeutic vaccine in clinical trials of its second-generation HIV immunotherapy IR103, based on the company's patented, whole-inactivated virus technology.
A therapeutic vaccine for HIV would be used to bolster the immune system to more effectively mount a sustained attack against HIV-infected cells by allowing the body to create and maintain a memory of the core proteins making up the virus by exposing it to an inactivated form of HIV that could not infect or destroy the immune cells, said the firm.
To create such a vaccine, cells chronically infected with the virus require growth and expansion in large quantities, after which point the resulting whole virus contained in the clarified production medium is then inactivated and further purified, the firm said.
More than 25m people have died since HIV was first recognised in 1981 and despite medical advances, the worldwide pandemic continues to claim more than 3.1m lives each year.
Various antiviral treatments are used by some patients to help keep the virus at bay but new, effective and affordable treatments are still desperately needed in order to treat all of the 40m adults currently living with the disease worldwide - many who are currently receiving no treatment at all.
