Recombinant vector technology offers a powerful way of extending long-standing experience with egg-based manufacturing to
the fight against pandemic and neglected diseases. AdCEV vectors for use in eggs are being developed along with facilities
that can be reconfigured to produce a sustainable mix of high value biologics and low cost vaccines in any economic context.
The recombinant adenovirus/egg technologies create a new category of production platform with unique economic, technical,
and safety characteristics. The power to engineer the molecular processes of antigen production result in increases in yield,
fidelity of product, and expansion of options for downstream processing. Changes in these parameters have far-reaching effects
at the manufacturing process level including higher and more predictable yields from fewer eggs. This will potentially effect
quality control issues that have traditionally dogged the egg-based vaccine industry.
A global system that can identify a pathogen, qualify targets in its lifecycle, then rapidly design and manufacture specific
interventions to neutralize it is one of the most exciting promises of the post-genomic era. Ironically, such a system has
existed for influenza for many decades, successfully operating on an annual cycle. Although it is ultimately desirable to
move away from manufacturing in embryonated eggs, much can still be learned from this system. By offering significant improvements
in biosafety and disruptive economics of scale, AdCEV/egg based systems could empower a sustainable, distributed manufacturing
model more accessible to low and middle income countries and more resistant to biosecurity threats.
Eluemuno R. Blyden, PhD, is the founder and CEO of AfriVax, Inc., Seattle, WA,
Peter K. Watler, PhD, is a principal consultant and chief technology officer at Hyde Engineering + Consulting, Inc., South San Francisco, CA.
1. Matthews JT.Egg-Based Production of Influenza Vaccine: 30 Years of Commercial Experience. The Bridge. 2006;36(3): 17–24.
2. Hayden FG, Howard WA, Palkonyay L, Kieny MP. Report of the 5th meeting on the evaluation of pandemic influenza prototype
vaccines in clinical trials: World Health Organization, Geneva, Switzerland, 12–13 February 2009. Vaccine. 2009 Jun 24;27(31):4079–89.
3. Fedson DS.New technologies for meeting the global demand for pandemic influenza vaccines. Biologicals. 2008 Nov;36(6):346–9.
4. Kieny MP, Costa A, Hombach J, Carrasco P, Pervikov Y, Salisbury D, et al. A global pandemic influenza vaccine action plan.
5. Grabko VI, Blyden ER. Recombinant eggs and gene cloning and expression vectors based on avian adenoviruses. 2001. PCT Publication:
6. Corral T, Ver LS, Mottet G, Cano O, Garc쟭Barreno B, Calder LJ, et al. High level expression of soluble glycoproteins in
the allantoic fluid of embryonated chicken eggs using a Sendai virus minigenome system. BMC Biotechnol. 2007;7:17.
7. Oliver Wyman. Influenza Vaccine Strategies for Broad Global Access. Seattle, Wa: Program for Appropriate Technology in
Health (PATH); 2007.
8. FDA Warning Letter. Merck & Company, Inc., April 28, 2008.