Vaccines must be regulated to ensure the safety of users and to protect the industry as a whole.
Dr Santosh Nanda, Microbiologist/Primary Reviewer, CBER, FDA joined us at the World Vaccine Congress in Washington 2012 to give a regulatory perspective for plant-based vaccines:
- Issues related to plant cell-substrate
- Issues related to manufacturing products in plant cell substrate
- Plant-based product related issues
From a regulatory perspective there are many considerations for Plant-based Vaccines, ranging from the technology and manufacturing to product considerations. There are many cell-based vaccine manufacturing systems. Plant-based vaccine systems have many potential advantages, all of which must be regulated. They may eliminate live virus culture and use of animal components and can permit large scale, transient gene expression. They are adaptable to rapid scale-up of biomass and maintenance of surge capacity and can permit multiple antigen variants and formulations to be produced.
Plant based vaccine technologies must also be considered from a regulatory stand point. For example, consideration is given to antigen expressed in Agrobacterium through plasmid, bacteria used to infect plants, purified plant-derived antigens and rapid production, to name but a few.
Further considerations for Plant-Based products include the environmental impact, the use of bioengineering, genetic stability and product consistency. Why not download the full presentation and discover more about the regulation behind Plant-based vaccines. Please take a look and give us your opinion by commenting below!