Biotech Values

[genisi]

In the process of making Copaxone you need to create the polypeptides of the mixture. During the polymerization the order of adding the four amino acids is important and so is the ratio. Even if replicated and the formulation contains the necessary components, in the same amounts, it may not be in the same sequence proportions. Change one bit and the process yields different polymers of differing sequence. So, if you don't know all steps of the original process you need to reverse engineer it. This is far more difficult than purification and analysis of sugars. MNTA has reverse engineer the Copaxone production process but I believe they will have to prove they end up with an identical product.