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

Life Sciences, Pharmaceutical,
  • Thursday, November 03, 2022

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.


Oliver Buettel

Oliver Buettel, Director Product Management and Applications, Analytik Jena US LLC

Oliver Buettel obtained his degree in applied chemistry from Hochschule Fresenius in Germany. After teaching lab classes for two years, he joined Analytik Jena in Germany as an Application Specialist in Atomic Spectroscopy. During his career with Analytik Jena he held various positions in the spectroscopy department. In 2017, he transferred to Analytik Jena US to support the local organization as Director of Product Management and Applications.

Message Presenter

Who Should Attend?

The following professionals in the pharmaceutical industry:

  • QC Managers and Technicians
  • Production Managers and Technicians
  • R&D Managers and Technicians

What You Will Learn

Attendees will gain insights into:

  • Comparison of combustion elemental analysis with traditional methods for total nitrogen determination
  • Principle of nitrogen determination by catalytic combustion
  • Data integrity and regulatory compliance

Xtalks Partner

Analytik Jena

Analytik Jena is a leading provider of high-end analytical measuring technology, of instruments and products in the fields of biotechnology and molecular diagnostics, as well as of high quality liquid handling and automation technologies. Its portfolio includes traditional analytical technology, particularly to measure concentrations of elements and molecules, as well as systems for bioanalytical applications in the Life Science area spanning the highly complex analytic cycle of a sample from sample preparation to detection. Automated high-throughput screening systems for the pharmaceutical sector are also part of this segment’s extensive portfolio. Analytik Jena´s products are focused to offer customers and users a quality and the reproducibility of their laboratory results. Services, as well as device-specific consumables and disposables, such as reagents or plastic articles, complete the Group’s extensive range of products. Analytik Jena is part of the Swiss Endress+Hauser Group.


With its acquisition of Analytik Jena AG, Endress+Hauser as a leader in process measurement technology was to enter the market for lab analysis technology. In the laboratory business, we often deal with the same customers as in the process technology business.


In the future, Endress+Hauser together with Analytik Jena want to accompany them from the laboratory through to the processes – from research to product and process development right up to production and quality control.

 Market served

Analytik Jena follows its mission to achieve excellent usability for the customer in the long run. The Company is therefore strengthening its industry expertise. Not every customer is the same. The company, the industry, the range of applications with which the customer works – these are all very specific. The tasks and requirements of the customers are also individual. Analytik Jena meets the customer’s needs with its portfolio and market strategy, offering a range of products with a strong industry focus. In-depth industry knowledge is already used to shape the development of the products and technology of tomorrow.

Products, Services and Capabilities

With its core expertise in optical spectroscopy and elemental trace analysis, the Company is a leading producer of high-performance analytical instruments, and modern, innovative solutions which ensure its growth through unique technological positions. With its broad range of offerings in the Life Science area – from DNA purification through robotics, standard and real-time PCR instruments, and various detection processes to kits for molecular diagnostics in food and water analysis –, Analytik Jena addresses a rapidly growing and competitive global market that is particularly characterized by lucrative follow-up business. Automated high-throughput screening systems for the pharmaceutical sector are also part of this segment’s extensive portfolio. 

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