Dr. Stephan Hellwig from Fraunhofer IME joined us at the World Vaccine Congress 2012 in Washington to answer the question: Is yeast on the rise?
The Ama1 project from Fraunhofer IME is sponsored by the European Vaccine Initiative, leading the European effort to develop effective, accessible, and affordable vaccines against diseases of poverty. EVI's vision:
"…a world free of the intolerable burden of diseases of poverty within the coming decades."
The Ama1 project (Apical Membrane Antigen) induces broader allelic recognition and growth inhibition responses in Rabbits. The process of development of this project is an upstream process development to amend the post-IMAC stability issue and address purity issues. The scaleup and transfer GMP concerns the raw materials and consumables specification, as well as API specs and QC. In total, there are 3 GMP batches.
The Ama1 process takes place over 7 days: shake-flask cultivation, seed bioreactor, production bioreactor, centrifugation, filtration, IMAC, HIC, and finally buffer exchange.
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