Here we propose a point-of-care (POC) alternative to insulin manufacturing which has the potential of putting insulin in the hands of diabetic patients from all walks of life. Insulin is a 51 amino acid, peptide hormone which is responsible for the metabolic regulation of glucose in humans. While insulin was the first biologic to be approved by the FDA, current barriers to biosimilar entry have resulted in price gouging by manufacturers, further resulting in reduced availability and economic accessibility. Additionally, an estimated 100 million individuals globally are expected to be diagnosed with Type 2 Diabetes by the year 2030. To address these issues, we start by genetically engineering a novel proinsulin analog that can be rapidly expressed in both prokaryotic and eukaryotic cell-free systems (CFS). The design of this analog will allow for the coupling of purification and enzymatic conversion of proinsulin, such that both steps can be performed in tandem, resulting in an active insulin product. This insulin can then be purified to greater homogeneity via a series of common purification steps, which also inform the quality of the product. Additionally, all these manufacturing steps have the potential to be automated using the Bio-MOD platform, previously shown to consistently manufacture biologics at the POC.

Alternative approaches to insulin manufacturing using a cell-free system

ACS Spring 2022

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