Flu Vaccine Production on Track in Hwasun, South J
Writer
administ
Posted at
2009-11-10
Amid growing flu fears, all eyes are now on this vaccine factory of local drug maker Green Cross.
The idea of having a domestic vaccine producer goes back to 2003, when the then Ministry of Commerce (now the Ministry of Knowledge Economy) emphasized the necessity to prepare for a flu pandemic, which generally emerges every 30 years.
But few pharmaceutical companies, both at home and abroad, dared join the project at first because the vaccine business requires massive start-up costs. In addition, vaccine companies have to maintain high levels of continuous investment to keep up with ever-adapting flu strains.
Green Cross, one of the nation's biggest pharmaceutical companies, suggested moving its vaccine production line in Yongin, Gyeonggi Province, to Hwasun, South Jeolla Province, and became a business partner for the government-proposed project.
With the establishment of the factory in September last year, Korea has become the world's 12th country - the second in Asia - that has the capacity to produce flu vaccines using its own techniques.
And it didn't come a moment too soon.
Not a year since the factory came online, the H1N1 virus swept the globe, killing thousands, including four Koreans, and infecting hundreds of thousands more.
The green-colored factory appears after a 40-minute drive from Gwangju Airport. Consisting of five buildings, the facility is situated on a 10-square kilometer site within the area's industrial complex.
The five-story "Flu Building," where the main process of the vaccine production takes place, stopped manufacturing seasonal flu vaccines last month to concentrate on the H1N1 virus vaccine.
Greeting a group of reporters and government officials who visited the factory last week - the last of such tours, says the company - a factory official jokingly said they would have no problems meeting the original vaccine schedule if politicians and journalists would stop touring the facility and slowing them down.
Visitors are allowed to look around only the building's second floor, which produces the antigen, a main component of the flu vaccine that prompts the generation of antibodies.
Armed with protective shoes and outfits, they get a glimpse of the process shown through windows of some 50 workrooms. Their entrances are distinguished with colors, yellow doors for equipments and blue doors for staff members.
"This Hwasun factory is equipped with facilities and systems more excellent than those of international companies such as Sanofi Avantis and GlaxoSmithKline," said Lee In-je, production head of the factory.
"The rate of antigen purification also shows a higher level, five to 50 times of those in other countries," he added.
Green Cross started the production of the new flu vaccine in early July after receiving the seed stock of the virus from the U.S. Centers for Disease Control and Prevention. The seed virus grows rapidly in chicken eggs, so drug companies are using them to make hundreds of millions of doses of the vaccine.
Almost 135,000 chicken eggs per day, which are produced in clean farms without antibiotics, are delivered to the factory. Each egg is injected with the H1N1 flu virus and fertilized for three days. Then the virus is harvested and separated by a centrifugal evaporator to get a purified vaccine liquid.
The process takes 11 days. Most elements of production are conducted automatically, so just 47 of the total 270 staff are involved in actual vaccine production.
The remaining eggs, from which the virus is extracted, are "cooked" and crushed to be used as fertilizer.
If there are no significant delays, Green Cross says almost 7 million doses of the flu vaccine, tentatively named "Greenflu-S," will be available within the year. An additional 2 million doses will be produced early next year. The company is considering stretching the batches by using an adjuvant, an immune-system stimulator that helps produce more antibodies.
Because the safety of adjuvant-boosted flu vaccines has not yet been determined for pregnant women and children, countries are producing the vaccine with and without it.
Along with another 3 million doses from the U.K.-based GlaxoSmithKline, the government plans to vaccinate more than 13 million people, or 27 percent of the total population, starting in mid-November.
With results of the vaccine's test trials on humans due out today, the Korea Drug and Food Administration has already embarked on its approval procedure for a prompt vaccination to be offered.
"We know people have concerns over the safety of the new vaccine as much as they fear the virus," said Lee Jeong-seok, director of the biopharmaceutical division at the drug agency.
"An earlier approval doesn't necessarily mean health officials ignore the safety issue. Only some paper jobs and administrative procedures will be conducted more promptly than usual."
Source: The Korea Herald (September 7, 2009)
The idea of having a domestic vaccine producer goes back to 2003, when the then Ministry of Commerce (now the Ministry of Knowledge Economy) emphasized the necessity to prepare for a flu pandemic, which generally emerges every 30 years.
But few pharmaceutical companies, both at home and abroad, dared join the project at first because the vaccine business requires massive start-up costs. In addition, vaccine companies have to maintain high levels of continuous investment to keep up with ever-adapting flu strains.
Green Cross, one of the nation's biggest pharmaceutical companies, suggested moving its vaccine production line in Yongin, Gyeonggi Province, to Hwasun, South Jeolla Province, and became a business partner for the government-proposed project.
With the establishment of the factory in September last year, Korea has become the world's 12th country - the second in Asia - that has the capacity to produce flu vaccines using its own techniques.
And it didn't come a moment too soon.
Not a year since the factory came online, the H1N1 virus swept the globe, killing thousands, including four Koreans, and infecting hundreds of thousands more.
The green-colored factory appears after a 40-minute drive from Gwangju Airport. Consisting of five buildings, the facility is situated on a 10-square kilometer site within the area's industrial complex.
The five-story "Flu Building," where the main process of the vaccine production takes place, stopped manufacturing seasonal flu vaccines last month to concentrate on the H1N1 virus vaccine.
Greeting a group of reporters and government officials who visited the factory last week - the last of such tours, says the company - a factory official jokingly said they would have no problems meeting the original vaccine schedule if politicians and journalists would stop touring the facility and slowing them down.
Visitors are allowed to look around only the building's second floor, which produces the antigen, a main component of the flu vaccine that prompts the generation of antibodies.
Armed with protective shoes and outfits, they get a glimpse of the process shown through windows of some 50 workrooms. Their entrances are distinguished with colors, yellow doors for equipments and blue doors for staff members.
"This Hwasun factory is equipped with facilities and systems more excellent than those of international companies such as Sanofi Avantis and GlaxoSmithKline," said Lee In-je, production head of the factory.
"The rate of antigen purification also shows a higher level, five to 50 times of those in other countries," he added.
Green Cross started the production of the new flu vaccine in early July after receiving the seed stock of the virus from the U.S. Centers for Disease Control and Prevention. The seed virus grows rapidly in chicken eggs, so drug companies are using them to make hundreds of millions of doses of the vaccine.
Almost 135,000 chicken eggs per day, which are produced in clean farms without antibiotics, are delivered to the factory. Each egg is injected with the H1N1 flu virus and fertilized for three days. Then the virus is harvested and separated by a centrifugal evaporator to get a purified vaccine liquid.
The process takes 11 days. Most elements of production are conducted automatically, so just 47 of the total 270 staff are involved in actual vaccine production.
The remaining eggs, from which the virus is extracted, are "cooked" and crushed to be used as fertilizer.
If there are no significant delays, Green Cross says almost 7 million doses of the flu vaccine, tentatively named "Greenflu-S," will be available within the year. An additional 2 million doses will be produced early next year. The company is considering stretching the batches by using an adjuvant, an immune-system stimulator that helps produce more antibodies.
Because the safety of adjuvant-boosted flu vaccines has not yet been determined for pregnant women and children, countries are producing the vaccine with and without it.
Along with another 3 million doses from the U.K.-based GlaxoSmithKline, the government plans to vaccinate more than 13 million people, or 27 percent of the total population, starting in mid-November.
With results of the vaccine's test trials on humans due out today, the Korea Drug and Food Administration has already embarked on its approval procedure for a prompt vaccination to be offered.
"We know people have concerns over the safety of the new vaccine as much as they fear the virus," said Lee Jeong-seok, director of the biopharmaceutical division at the drug agency.
"An earlier approval doesn't necessarily mean health officials ignore the safety issue. Only some paper jobs and administrative procedures will be conducted more promptly than usual."
Source: The Korea Herald (September 7, 2009)