
Firstly, recombinant insulin, produced through industrialized fermentation and standardized purification, ensures high purity and batch-to-batch consistency, which is the foundation of biopharmaceutical quality control. Secondly, as a human-derived sequence, recombinant formulations exhibit significantly reduced immunogenicity, leading to better patient tolerance. Thirdly, clinical PK/PD data indicate that recombinant formulations are at least equivalent to traditional semi-synthetic insulin in terms of hypoglycemic effect and safety, and they provide a molecular modification platform for rapid-acting or long-acting analogs, meeting the needs of individualized treatment. Finally, with continuous optimization of fermentation and purification processes, recombinant production possesses the advantages of scalability and controllable costs, enabling long-term stable supply.
Limitations and Challenges of Recombinant Human Insulin: 1. ...