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Mixture of three amino acids as stabilizers replacing albumin in lyophilization of new third generation recombinant factor VIII GreenGene F.

Biotechnol Prog. 2012 Sep 26;

Authors: Paik SH, Kim YJ, Han SK, Kim JM, Huh JW, Park YI


A formulation with stabilizers replacing albumin was develop for lyophilization of recombinant FVIII to achieve stability and eliminate safety issues of blood-derived albumin. L-Arginine (hydrophilic amino acid, positively charged side chain), L-glutamic acid (hydrophilic amino acid, negatively charged side chain), and L-isoleucine (hydrophobic amino acid, non-polar) was selected as stabilizers and the mixture of the three amino acids were optimized. The mixture had results comparative with albumin and other commonly used stabilizers showing good preservation of recombinant FVIII during lyophilization, robust stability with consistently high recovery of FVIIII, very low aggregate formation, and good storage stability without alterations in protein characteristics. In vivo test results showed the efficacy was maintained and had no signs of toxicity. The study demonstrated the three amino acid mixture acts as a good stabilizer for lyophilization of recombinant FVIII and as a safe excipient. © 2012 American Institute of Chemical Engineers Biotechnol. Prog., 2012.

PMID: 23011837 [PubMed - as supplied by publisher]