Analysis of Sialic Acid Content

Recombinant protein drugs, derived from animal and plant sources through biotechnology, are protein products with specific biological activities used in the prevention, treatment, and diagnosis of diseases in humans, animals, and plants. Compared to small molecule drugs, recombinant protein drugs offer high activity, high specificity, and low toxicity, making them highly attractive to researchers. They are currently widely applied in the treatment of tumors, autoimmune diseases, metabolic disorders, geriatric diseases, and degenerative conditions.

 

Glycosylation is a crucial post-translational modification in recombinant protein drugs. Sialic acids (SAs) are a family of neuraminic acid derivatives containing nine carbon atoms and an acidic amino sugar pyranose structure. They are usually found at the non-reducing end of glycoprotein glycans, with N-acetylneuraminic acid (NANA) being the predominant form. SA content significantly impacts the half-life and biological activity of recombinant protein drugs. Therefore, analyzing SA content is a key step in biopharmaceutical development.

 

The main methods for determining SA content in recombinant protein drugs include the resorcinol method, enzymatic assays, and high performance liquid chromatography (HPLC). The resorcinol method is a traditional approach that is fast, accurate, and reproducible, but it lacks sensitivity and has a narrow linear range. Although enzymatic assays are accurate and sensitive, they are costly, involve complex protocols, and also have a narrow linear range. In contrast, HPLC offers rapid, accurate, sensitive, and reproducible determination of SA content with a broad linear range, making it the preferred method for analyzing SAs in recombinant protein drugs and other biopharmaceuticals.

 



Figure 1. SA Content Analysis in Biologics-An Illustration

 

MtoZ Biolabs provides a comprehensive HPLC-based SA content determination package for recombinant protein drugs, leveraging advanced chromatography platforms and a team of experts. Simply communicate your experimental objectives and provide samples, and MtoZ Biolabs will handle the rest, including sample preparation, instrument analysis, data interpretation, and reporting. Reach out to us for a complimentary consultation.