Recombinant proteins guidelines

GUIDELINES FOR THE PRODUCTION AND ACCEPTANCE OF RECOMBINANT PROTEINS IN BIOLOGIC SYSTEMS... 

Since the number of recombinant protein drugs will substantially increase over the next decade, analytical as well as bioan-alytical methods for the characterization of such macromolecules will definitively gain in importance. Especially the vaKdation of bioanalytical methods is of key importance to allow an accurate description of protein drugs. This requires harmonized guidelines, which are not yet existing but seem to be on the way, to accelerate drug development. 

Factor IX Replacement Hemophilia B therapy may include recombinant (produced via transfection of mammalian cells with the human factor IX gene) or plasma-derived (concentrate from pooled plasma) factor IX (see Table 64-2). Guidelines for choosing the factor-concentrate formulation for hemophilia B are similar to the guidelines for hemophilia A. However, older-generation factor IX concentrates containing other vitamin K-dependent proteins (e.g., factors II, VII, and IX), called prothrombin complex concentrates (PCCs), have been associated with thrombogenic side effects. Consequently, these products are not first-line treatment for hemophilia B.11... 

The most recent UKHCDO guideline (September 2003) states [15] To reduce the chance of infection by exogenous vimses in a recombinant concentrate, consideration should be given to choosing one, where available and Hcensed, that is manufactured with the least addition of human or animal protein. ... 

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