ID Biomedical's proprietary cell culture-based manufacturing process is being developed as a possible future replacement to the classical egg-based manufacturing process currently used by all flu vaccine manufacturers, including ID Biomedical. The technology has particular application to manufacturing vaccine in the event of an influenza pandemic. This grant will allow ID Biomedical to further develop and conduct early-stage human trials of its cell culture-based influenza vaccine.
Commenting on the award, ID Biomedical's senior vice president of development, Dr. Ronald Ellis said, "We are delighted to have received funding from the NIH to develop our cell-derived influenza vaccine. We had shown a few years ago that our cell-derived vaccine manufactured by a prototype process was comparable in terms of safety and immunogenicity to our licensed egg- derived vaccine, Fluviral®. This NIH grant enables IDB to continue this development toward a commercial process that should produce a vaccine with a safety and immunogenicity profile that fully meets the requirements for any influenza vaccine. Moreover, the grant also enables the development of and manufacturing process for a pandemic vaccine, should one be needed."
Cell culture-based manufacturing technologies offer a number of potential advantages over traditional egg-based manufacturing processes, including a reduction in the time required to produce influenza vaccines and potentially improved effectiveness. Additionally, persons with egg allergies could take the vaccine, whereas egg-based vaccines are contra-indicated in this particular population.
"There is increasing concern around the world that an influenza pandemic, which could have disastrous consequences for public health, is imminent. The development of effective cell culture-based influenza vaccines is an important step forward both for addressing the pandemic threat as well as for use during the annual periods between pandemics. Cell culture technologies have the potential to overcome the problems associated with growing some influenza virus strains in eggs, and are a pathway to more rapid, and more efficient, production of influenza vaccines. The awarding of this grant is especially timely, considering the evolving situation with avian influenza in
"This award is not only important for the development of influenza vaccines that address pandemic strains of the flu virus, but in the long term, we need to consider the possibility that cell culture-derived flu vaccine could eventually supplant eggs as a source of vaccine," said Dr. Anthony Holler, ID Biomedical's CEO. "Accordingly, the development of our proprietary cell-based technology may be important for our annual injectable product, Fluviral, as well as our intra-nasal product in development, FluINsure. In addition, this capability simply adds to the valuable portfolio of assets we have in the flu vaccine business. While we build an influenza franchise, it is important that we focus not just on the short term but also on the future."
About Cell Culture Influenza Vaccine
The classical influenza vaccines currently on the market worldwide are produced from viruses grown in eggs. While classical egg-derived vaccines are considered highly effective, public health officials see a need for an alternative manufacturing technology. Utilizing cell culture production technology offers such an alternative.
The cell-culture derived production technology offers flexibility in terms of production delays as production time is decreased. Further, the current technology relies on some cumbersome logistical components, such as ordering eggs well in advance of production schedules. Cell culture technology has the potential to enhance production capacity and consistency and to reduce the time required to produce influenza vaccines; therefore, potentially allowing a manufacturer to meet more easily the additional demand for production of a vaccine in the event of a pandemic.
From the healthcare perspective, the advantages include potentially improved protection, given that cell-grown viruses may more closely resemble the wild strains found in nature. Also, the virus is reproduced in a proprietary cell-culture system (fermenters) rather than the conventional method that uses embryonated hens' eggs. Such a vaccine may be made available to those who have egg-protein allergies for whom the conventional egg-grown vaccine is contra-indicated.
Additionally, the cell-culture derived technology would provide the potential ability to grow a pandemic avian viral strain that might be lethal or deleterious to eggs. There is currently a potential barrier to grow avian strains in eggs, since they have the potential to destroy the eggs. The influenza vaccine program of ID Biomedical will include the development of both the injectable and intra-nasal influenza vaccines based on its cell-culture production technology.
Source: ID Biomedical