How Biopharmaceuticals Help to Protect Against Hepatitis

Better HealthCareers
Jul 28, 2022  |  4 min read

Sartorius is Part of the Solution

This article is posted on Sartorius Blog.


On World Hepatitis Day 2022, the World Health Organization (WHO) is highlighting the need for providing people with better access to prevention, treatment and care for viral hepatitis, an inflammation of the liver caused by viruses. Sartorius supports customers to commercially produce the cell lines needed for type B vaccines and other recombinant protein vaccines.
 

Recombinant proteins have transformed the vaccine industry since the early 1980s, enabling the development of safe and effective vaccines. Today, they make up a significant part of the vaccine pipeline, with promising candidates for a range of virus-related diseases, such as those caused by the respiratory syncytial virus (RSV), human immunodeficiency virus (HIV), a new generation of influenza vaccines and hepatitis B.
 

Hundreds of thousands are affected by chronic hepatitis B or C

There are five main strains of the hepatitis virus, known as types A, B, C, D and E. They differ, for example, in the way and mode of transmission, the severity of the disease and geographical distribution.

While hepatitis A and E are considered less dangerous and patients can recover without treatment, infections with virus types B, C and D are critical, in part because they often go undetected. In cases of chronic infections, there is a risk of late effects including cirrhosis of the liver or liver cancer.


According to the WHO, an estimated 296 million people worldwide were living with chronic hepatitis B in 2019, with 1.5 million new infections each year.


There is a preventive vaccination against the hepatitis B virus that protects up to 95 percent of those vaccinated for around ten years. This is a recombinant protein vaccine that is produced using biotechnology.

Learn more about vaccine development

Sartorius technologies support the production of recombinant protein vaccines

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Effective and safe: recombinant vaccines against hepatitis B

Recombinant vaccines usually contain a single inactive antigen of a pathogen. In the case of hepatitis B, the gene containing the blueprint for the desired antigen was already isolated in the 1970s. To produce a vaccine today, the DNA sequence is inserted into a host organism, usually yeast cells, which then multiply in fermenters and produce the hepatitis B antigen. At the end of the process, the yeast cells are broken up to extract the desired antigens. Finally, the antigens are purified and formulated into vaccines.

Sartorius' part in the solution: innovative technologies

Sartorius products are involved in the production of several of the nearly two dozen hepatitis B vaccines that are currently available. From the development of highly productive cell lines to purification, Sartorius technologies help vaccine manufacturers achieve results more quickly during cell line development and get the most out of their production processes.

The high-throughput cell culture systems Ambr® 15 and Ambr® 250 accelerate the development of stable, productive and safe cell lines through multiparallel mini-bioreactors and automated functions.

The still relatively small protein production in the Ambr® can be increased seamlessly thanks to Biostat® disposable bioreactors such as Biostat® RM or the Biostat® D-DCU. Here, the yeast cells find optimal growth conditions and process analytical technologies such as BioPAT® Spectro enable process control and monitoring.  

Once enough proteins have been produced, harvesting and purification take place: Yeast cell debris and impurities need to be removed. Hydrosart® is a high-performance crossflow membrane for this process step.

Sartorius also has a wide range of chromatography resins to ensure fast and efficient purification of the antigen and concentration of the product. Sterile filters such as the Sartopore® Platinum prevent microbial contamination in the final filling - and ensure that patients receive safe vaccines.

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