They are proteins encoded by recombinant DNA that has been cloned in an expression vector that supports expression of the gene and translation of m-RNA.
These are used in the clinic therapies include recombinant hormones, interleukins, growth factors, and enzymes for treating major diseases as diabetes, myocardial infarction, hepatitis, Chron`s disease and cancer.
Therefore, from AMSbiopharma, as in the case of other biopharmaceuticals, a complete characterization in line with ICH Q6B is offered:
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