Manufacturing
Unigene is a pioneer in the recombinant expression and manufacturing of therapeutic peptides. The Company has a fully GMP-compliant manufacturing facility for both the production of API as well as dosage forms of final product.
Unigene has developed a proprietary E. coli expression system that offers advantages over chemical synthesis as well as other recombinant technologies.
Unigene’s E. coli Expression System
- Robust yield and purity
- Fermentation yields between 400 and 1300 mg/L
- Number of purification steps significantly reduced, compared to intracellular expression technologies, achieving greater than 98% purity
- Minimal process-related contaminants
- Readily scalable to produce hundreds of kilograms to metric tons of peptide per year
- Highly-efficient, not requiring cell lysis or cleavage (chemical or enzymatic) from a fusion partner
- Significant cost savings compared to other manufacturing technologies
Unigene has also developed proprietary, scalable enzymatic technology for in vitro amidation of peptides that require a C-terminal amide group for biological activity.
Amidation of peptides is an important capability because:
- Approximately 50% of all peptide hormones and neurotransmitters possess an amide group at the C-terminus
- Absence of the amide group can significantly reduce or eliminate peptide biological activity
- Addition of an amide group at the C-terminus can often enhance stability, bioavailability and biological activity of non-amidated peptides
Peptide Amidation Reaction Catalyzed by peptidyl-glycine alpha-amidating monooxygenase (PAM)
