Recombinant active ingredients

Streptokinase is a 48 kDa extracellular bacterial protein produced by several strains of Streptococcus haemolyticus group C. Its ability to induce lysis of blood clots was first demonstrated in 1933. Early therapeutic preparations administered to patients often caused immunological and other complications, usually prompted by impurities present in these products. Chromatographic purification (particularly using gel filtration and ion-exchange columns) overcame many of these initial difficulties. Modern chromatographically pure streptokinase preparations are usually supplied in freeze-dried form. These preparations (still obtained by non-recombinant means) often contain albumin as an excipient. The albumin prevents flocculation of the active ingredient upon its reconstitution. 

PEG-Intron PEG-Intron is used for the treatment of hepatitis C. The product consists of a covalent conjugate of the recombinant interferon- -2b with monomethoxy polyethylene glycol (PEG) supplied in vials with 74/rg, 118.4/rg, 177.6/rg, or 222/rg of the active ingredient and 1.11 mg sodium phosphate (dibasic,anhydrous),l.ll mg sodium phosphate (monobasic, dihydrate), 59.2 mg sucrose, and 0.074mg polysorbate 80. The powder is reconstituted with sterile water-for-injection. 

Comparability Program Fortical and Miacalcin NS differed in certain aspects, such as the use of recombinant versus synthetic salmon calcitonin and the use of different types and amounts of excipients. Given these differences, Unigene was required to submit data to establish that the findings of safety and efficacy for Miacalcin were relevant to Fortical (i.e., contain the same active ingredient and have comparable bioavailability) and that the formulation differences did not impact previous clinical profile [26,27],... 

Active and excipient chemical ingredients used in drug products may therefore be considered as BPCs. These materials can be made by chemical synthesis, fermentation, enzymatic reactions, recombinant DNA, recovery from natural materials, or a combination of the above. 

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