Enterovax Enterovirus 71 Vaccine
The Enterovirus-71 vaccine developed by our company is based on the virus strain B4 that is popular in Taiwan. It is manufactured with the bioreactor process and using serum-free cell culture technology with PIC/S GMP standards to ensure safety. Phase III clinical trial has been completed in Taiwan. After approval, it is expected to be the first Enterovirus-71 vaccine in Taiwan.
Recombinant Corona Virus Vaccine-Baculovirus System 2f vaccine
The COVID-19 vaccine independently developed by Adimmune Corp. is based on recombinant protein technology, and animal experiments have confirmed that the vaccine antibody response is excellent. According to the amino acid sequence of the S-protein SARS-CoV-2, a candidate vaccine fragment was designed, which was fused with the Fc fragment gene of human IgG1 antibody for the development of COVID-19 vaccine. It has now entered PIC/S GMP production and has been used in animals. The test can produce high-potency neutralizing antibodies. It has been shown to be safe and effective in animal toxicology tests, animal pharmacological tests and animal challenge tests. It entered the first phase of the clinical program in August ,and is also developing next generation COVID-19 vaccines to deal with virus mutations .
Thegene therapy and DNA vaccine technology are being developed quickly. When thesetechniques are commercialized, a massive amount of plasmid DNA will be indemand. However, the traditional method in preparing plasmid DNA cannot offersafe, effective, and high quality products. In addition, the productionprocedure and purification techniques are all regarded as business secretsamong the pharmaceutical industries, so the information on the mass productionof plasmid DNA is difficult to obtain. To provide a massive amount of purifiedplasmid DNA with stable quality for research, Adimmune Corporation collaborateswith DevelopmentCenter for Biotechnology( DCB ) to develop a plasmid productionprocedure that meets the GMP requirements. Adimmune Corporation has completedthe establishment of GLP and GMP pilot plant in 2006. The pilot plant canprovide the nucleic acid medication for the preclinical trial, the phase I andphase II clinical trial to facilitate the progress of developing new drugs.
Development of Baculovirus Expression Vector System (BEVS) for the production of Recombinant H7N9-HA vaccine
Human infection with a newly emerged avian-origin influenza A/H7N9 virus was first confirmed in March 31, 2013, in China. To date there have been 1,224 cases of human infection caused by H7N9 virus in twelve provinces and two municipalities in China, with 20–30% mortality rate among infected individuals. The clinical research reported that most of patients infected with the novel H7N9 virus exhibit severe illness, including pneumonia and acute respiratory distress syndrome, with high rates of intensive care unit admission or death, suggesting it is highly pathogenic and high fatality rate to human.
The most effective way to combat influenza is through the vaccination of the public. However, a minimum of 5–6 months is needed to develop an influenza vaccine using the traditional egg-based vaccine approach. The influenza hemagglutinin protein (HA), the active ingredient in the current vaccine, can be expressed in insect cells using the baculovirus expression vector system and purified rapidly. An influenza vaccine based on such a recombinant antigen allows a more timely response to a potential influenza pandemic. Adimmune was awarded a grant from the Ministry of Economic Affairs (MOEA)’s “A+ Industrial Innovation R&D Program to support this project from manufacture to clinical trials.
Developmentof Inactivated Japanese Encephalitis Vaccine Produced bySerum-FreeMicrocarrier Single Used Bioreactor System
Japanese encephalitis (JE) is an epidemic disease not only in Japan but also in a wide area from South to South East Asia. About 50 000 cases have been reported per year in these areas.
Thecurrent mouse brain-derived JE vaccine is highlypurified and its safety has been established. However, some theoretical risks remain: adventitious infectious agents and traces of impurities derivedfrom mouse brains may lead to adverse neurological events. To circumvent the possible risks associatedwith the current vaccine, we developed a production system for JE vaccine derived from Vero cells.
Adimmne have established a manufacturing system o for a Vero cell-derived inactivated Japanese encephalitis vaccine at a 50 L scale bioreactor. The production system involves expansion of Vero cells usingmicrocarrier, followed by virus infection. The downstream purification processes are similar to those used for the current EV71 vaccine; cell removal, concentration and removal of low-molecular weight impurities by membrane filtration, formalin-inactivation, column chromatography are conducted. The antigen obtained from the manufacturing system was highly purified and its physico-chemical and immunological properties were comparable with those of antigen derived from mouse brains. Production system is very simple and could be easily scaled-up to allow vaccine production at a several thousand liter scale.