Commercialization Status of Vaccines Produced Using Hansenula polymorpha Expression System

One of the most popular approaches involves introducing foreign genes into yeast cells and constructing recombinant yeast engineering strains to express the target genes. Hansenula polymorpha has many advantages: It can easily grow, quickly reproduce, be genetically modified, and process and modify foreign products. It also can produce non-toxic byproducts, withstand high temperatures, convert sugars, and ferment xylose to make ethanol directly.

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1.???? Recombinant Hepatitis B Vaccine

Chronic infection with Hepatitis B virus (HBV) poses a significant global public health concern. According to the World Health Organization (WHO), the global prevalence of Hepatitis B surface antigen (HBsAg) positivity is 2.5%, resulting in over 800,000 deaths annually, with the majority attributed to liver cirrhosis or hepatocellular carcinoma. The Hepatitis B vaccine, produced using specially treated HBV antigens, stimulates the production of specific virus antibodies in the body. These antibodies persist for a considerable period, preventing the survival and replication of future HBV invasions, thereby providing protection against Hepatitis B.

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2.???? Recombinant Human Papillomavirus (HPV) Vaccine

HPV is a highly infectious and prevalent sexually transmitted virus that can cause epithelial proliferation on the skin and mucous membranes of the human body. Persistent infection with HPV is the main cause of cervical cancer and precancerous lesions. Currently, the only commercially available product using the Hansenula polymorpha expression system is the Hepatitis B vaccine, while the recombinant HPV vaccine is still in the clinical trial phase.

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3.???? Recombinant Norovirus Vaccine

Norovirus has become one of the major pathogens causing acute gastroenteritis in humans. The incubation period of norovirus is relatively short, usually 12-48 hours. The most common symptoms of norovirus infection are diarrhea and vomiting, followed by nausea, abdominal pain, and fever. The period from October to March of the following year is the peak season for norovirus infections. Currently, there is no approved norovirus vaccine or specific antiviral drugs available globally. Clinical treatment mainly focuses on symptomatic or supportive care.

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Yaohai Bio-Pharma has extensive experience in the expression of recombinant vaccines using the Hansenula polymorpha system, covering strain modification/construction, strain bank establishment, process development, method development, and GMP production. Our services cover the preparation of pre-IND to Phase III clinical samples and commercial production in the fields of recombinant proteins/vaccines, plasmids/mRNA, and single-domain antibodies. We are committed to building a comprehensive and customized one-stop CRO/CDMO/MAH service platform. With a GMP-compliant plant and research and development center, we provide customized services ranging up to 7,500L based on customer needs.

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For more details about Yaohai Bio-Pharma, kindly refer to the download page of our website.

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