2022 - Quality Control of Vaccines and Other Pharmaceutical Preparations by Total Nitrogen Determination

Protein-based therapeutics are widely used in prevention and treatment of diseases, such as cancers, diabetes and autoimmunity/inflammation. Therapeutic proteins include peptide hormones, monoclonal antibodies, cytokines, therapeutic enzymes, blood factors, vaccines and peptide antibiotics. In therapeutic protein production, it’s critical to control the level of proteins in the source material, intermediate and end products. Thus, total protein analysis is a method of choice. Here, the featured speaker will explore the quality control of vaccines and other pharmaceutical preparations.
In the featured study, the catalytic combustion method with chemiluminescence detection (CLD) was utilized for total protein analysis according to USP <1057> Method 7 and as described in the Pharm. Eur. Monograph 2.5.33, Method 7B. A simple, rapid and robust method was developed on the Analytik Jena multi N/C 2100S pharma — a Total Organic Carbon and Total Bound Nitrogen (TOC/TNb) analyzer specifically designed for pharmaceutical applications — to obtain total bound nitrogen. The TNb can be easily converted into total protein. Vaccine and allergen extracts were analyzed in this study. The allergen extracts usually contain high percent of glycerol which makes protein analysis challenging. The result demonstrated no analytical interference from the high glycerol content.
Join this webinar to gain insights into total protein analysis, and quality control of vaccines and other protein-based therapeutics by total nitrogen determination.