Pegylated Recombinant Human Interferon Alpha 2A

Pegylated Recombinant Human Interferon Alpha 2A, commonly known as PEG-IFN-α-2A, is a remarkable antiviral medication. It is designed to combat chronic hepatitis B virus (HBV) and chronic hepatitis C virus (HCV) infections in both adults and children who meet specific health criteria.

The innovation lies in its formulation: by covalently attaching polymers of ethylene glycol to the native IFN-α molecule, PEG-IFN-α-2A achieves a longer serum half-life and decreased renal excretion. This unique profile allows for convenient weekly administration while maintaining an acceptable toxicity profile. In essence, PEG-IFN-α-2A represents a significant advancement in antiviral therapy for these challenging conditions.

mPEG20K-OC(O)-Lys(mPEG20K-OCO)-OSu (Pegylation Reagent) is produced
starting from commercially available raw mPEG20K-OH material which is checked
for purity and quality by RPHPLC-Evaporative Light Scattering Detection (RP-HPLC-
ELSD) and SDS-PAGE (Barium/iodine staining). Safety measures for proper
handling and disposal of the reagents involved are carefully checked.
The synthetic reaction batch is performed using 20 grams of starting mPEG20K-OH which is reacted with lysine to obtain the branched dimer mPEG20K-OC(O)-Lys(mPEG20K-OCO)-OH .
The crude product of the synthesis is checked by RP- HPLC-ELSD to evaluate the yield, which is at least 85%.
The crude synthesis mixture contains apart the branched dimer, unreacted monomers and oligomers as side reaction products. The crude mixture is therefore purified by preparative chromatography to obtain mPEG20K-OC(O)- Lys(mPEG20K-OCO)-OH with yield at least 30% and purity at least 98% evaluated by RPHPLC_ELSD and SDS-PAGE.

Treatment with interferon supports the functions of the immune system and it is used in the treatment of Chronic Hepatitis, other viral infections and in cancer therapy .