KEYWORDS: Pharmaceutical peptides, enfuvirtide, hybrid process, large scale solid phase synthesizers.

IT CAN’T BE DONE
In the mid 1990’s, HIV drugs were few and patients quickly developed resistance to these pharmaceutical agents. The peptide enfuvirtide (T-20 or Fuzeon) showed good efficacy as one of the first-in-class viral entry inhibitors.  The challenge was the peptide contained 36 amino acids and the demand would require manufacturing at the multi ton scale. Prior to enfuvirtide, the vast majority of chemically synthesized peptides contained less than 30 amino acids, were highly potent and required less than 50 kgs per year.   Many peptide experts expressed that enfuvirtide “It can’t be done”.  It was too complex, the tonnage too large and the cost would be prohibitive with the production methods at that time.   

”OPENING DOORS” ON PEPTIDE MANUFACTURING AND PEPTIDE DISCOVERY  
Despite the challenges, Trimeris and Roche were able to successfully commercialize enfuvirtide.  As ...
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