By: Dr. John Kyndt ( Head Scientist of the Renewable Energy Program at Advanced Energy Creations Lab) and Dr. Aecio D’Silva.
Today vaccines are produced in three ways:
• grow live bacteria or viruses
• isolate killed bacteria or viruses
• produce recombinant vaccines
The latter are being produced by genetic engineering of bacteria like E. coli, or yeast, or mammalian cells. The problems with vaccines is the high production costs (cost concern), the lack of vaccines that can be readily produced in case of sudden outbreaks (production scale concern), and difficulties in vaccination campaigns (safety concern).
Is possible to produce vaccines in Algae through genetic engineering? We need to design algae as ‘production factories’ for highly efficient production of vaccines of interest. Some of the advantages of Algae vaccines are:
• Cheaper: No need for expensive mammalian cell lines.
• Safer: Free of mammalian viruses or toxins
• Efficient: algae resemble human cells more that bacteria
• Edible: given the right research algae vaccines could eliminate the need for injections.
Since the vaccine market has opened up for ‘blockbuster’ production about 4-5 years back there have been several success stories, and market potential is still growing, even in troubled financial times.
For example Wyeth’s pneumococcal conjugate vaccine (Prevnar) had $ 1.5 billion sales in 2005; Merck’s HPV vaccine (Gardasil) was approved in 2006 for the European market and had second quarter sales of ~ $ 300 million in 2008 and is continuing to grow.
Other ‘blockbusters’ vaccines that are on the rise are for Meningitis, Pneumococcal disease and Shingles. Vaccine pricing is nor ranging about $300-$400 per treatment course for new vaccines. Established vaccine treatments range around $20-$40 per treatment.
Cumulative annual spending on a child in the first six years on vaccines have gone from under $ 10 in 1980 to ~ $ 400 in early 2005 (adjusted for inflation), which shows the continuing growth in the market. In addition, there is a continuous public push to improve the development of vaccines.
In high income countries, this is pushed by bioterrorism and pandemic flu scares. In lower income countries, this is mainly stimulated by public sector. On the forefront are global initiatives like the $ 1.5 billion investment from Bill & Melinda Gates foundation for developing the Global Alliance for Vaccines and Immunization (GAVI)).
A large media is pushing the so-called ‘Green vaccines’ campaigns, which are driven by public fear of vaccine adjuncts and manufacturing techniques. Answering these issues will require innovative and alternative research and development.
In order to make feasible vaccine production we have to advance in the production media and delivery mechanisms (e.g. production in alternative organisms like Algae). We should address following concerns:
• Capacity constrains: Algae production is easily scalable
• Quality issues: No live human viruses or toxins in production
• Cost issues: Algae production cheaper than mammalian or CHO cell lines
In the initial research phase, we have to explore the production efficiency of several well established vaccines in Algae and determine the need for further research and time investment.
Once certain potential vaccine targets are established and proven to have market potential, we need to continue with larger scale production and purification. We must have all the equipment in place to perform and optimize the production, purification and quality testing of the targeted components.
This include small and large scale fermenters for optimizing cell growth and expression for production, and high-capacity protein purification systems, HPLC and immunoassays for quality control, and fractionation and packaging systems.
Still a long way to go, but it is worth and a great possibility to master the challenge and commercial opportunity of producing vaccines in algae through genetic engineering.