Semaglutide purification process sharing

Semaglutide, also known as somarutide, is a medication primarily utilized for the treatment of diabetes. Despite its intended use in diabetes management, it has gained popularity among non-diabetic individuals as a weight-loss aid, often recognized in the public domain as a “miracle drug” for weight reduction.

The current production process of semaglutide involves the combination of biological fermentation and chemical synthesis methods to achieve the product’s preparation. Using this approach, there is a propensity to generate a significant amount of unintended impurities, which hinders subsequent purification processes and results in relatively low recovery rates. Another production method involves traditional peptide solid-phase synthesis coupled with fragment condensation synthesis

Full Synthetic Semaglutide at Two Different Purity Levels: Insights into Purification Processes

Case Study 1:

Purification Insights for Semaglutide with Initial Peptide Purity at 59.65%

Figure 1. Sample 1 crude product analysis chart

Purification Process Overview:

Primary Purification

Chromatography Column: Ultisil® XB-C8, 10μm, 120Å

Figure 2. Primary purification chromatogram

Results: After the primary purification, the purity reached 94.56%, with a recovery rate of 80% and a sample loading of 0.6% of the column capacity.

Secondary Purification

Chromatography Column: Xtimate® C8, 10μm, 120Å

Figure 3. Secondary purification chromatogram

Results: After secondary purification, the purity was 99.65%, the recovery rate was 71%, and the loading amount was 0.56% of the filler amount.

Case 2:
Crude peptide purity 82.75%

Figure 4. Sample 2 crude product analysis chart

The purification process is as follows:

Chromatographic packing: Ultisil® XB-C8, 10μm, 120Å

Figure 5. Purification profile

Results: After the secondary purification, the purity increased to 99.15%, with a recovery rate of 71% and a sample loading of 0.62% of the column capacity.

Summary

For low-purity semaglutide, a two-step purification process was employed using Welch Ultisil® XB-C8, 10μm, 120Å, and Xtimate® C8, 10μm, 120Å columns. The final purity achieved was 99.56%, with a total recovery rate of 56.8%. The sample loading for the first and second purification steps was 0.6% and 0.56% of the column capacity, respectively.

For high-purity semaglutide, a single purification step using Welch Ultisil® XB-C8, 10μm, 120Å column resulted in a purity of 99.15%, with a recovery rate of 71%, and a sample loading of 0.62% of the column capacity.

Filler information