High-Yield Biosynthesis Process for Producing Insulin Lispro

Area of Science:

• Biochemistry
• Pharmaceutical Sciences

Background:

• Insulin lispro is a vital fast-acting insulin analogue for diabetes management.
• Existing production methods require optimization for efficiency and cost-effectiveness.

Purpose of the Study:

• To develop and validate a streamlined, cost-effective purification process for high-purity insulin lispro.
• To establish a scalable method for producing recombinant insulin lispro.

Main Methods:

• A three-step chromatography purification process was developed.
• The process involved fermentation, inclusion body recovery, renaturation, enzymatic digestion, and chromatographic purification.
• Analytical techniques including peptide mapping were used for characterization.

Main Results:

• The purification process yielded 475 mg/L of insulin lispro from L fermentation broth.
• The final product achieved 99.7% purity with minimal high molecular weight proteins (≤0.1%).
• Contaminants such as host cell proteins (2.31 ng/mg) and residual DNA (1.57 ng/mg) were significantly reduced.

Conclusions:

• The established three-step chromatography method is efficient and cost-effective for large-scale insulin lispro production.
• This process provides high-quality active pharmaceutical ingredients for diabetes treatment.
• The method supports the development of recombinant insulin analogs.