● SK chemicals Receives Market Approval for Its Cell-culture Influenza Vaccine “SKYCellflu” in Korea
SK chemicals announced that the Ministry of Food and Drug Safety (MFDS, formerly Korean FDA) has approved SKYCellflu®, the company’s cell culture-based seasonal trivalent influenza vaccine. With the approval of SKYCellflu, SK chemicals has become the first Korean vaccine manufacturer to use cell culture technology to produce influenza vaccine.
The cell culture production system used by SK chemicals has great advantages over the conventional egg-based production system that has been used for more than last 40 years for most of currently available influenza vaccines; it allows the production of a greater amount of influenza vaccine in a shorter amount of time, approximately one third of that required for the conventional process using fertilized chicken eggs, and it also has lower risk of safety issues such as allergic reactions to egg components. These advantages of cell culture production system allows enhanced preparedness against pandemic influenza as well as the shortage of seasonal influenza vaccine, thus, cell culture production system has been considered as an alternative production technique for influenza vaccine.
For the production of SKYCellflu, SK chemicals has developed a unique Madin-Darby Canine Kidney (MDCK)-derived cell line, named MDCK-Sky. MDCK cells have been found suitable for the virus production because of their high sensitivity to influenza virus, resulting in a high virus titer and a high yield of vaccine. However, their inability to grow in suspension has limited the density of cells and the production yield while increasing the complexity in manufacturing process. Therefore, in order to overcome these disadvantages, SK chemicals selected the most suitable MDCK-derived cell line that can be grown in suspension cultures with serum free media, thereby obtaining a reliable production yield with a relatively simple and highly efficient manufacturing process. Also, through its adaptation to the cell culture method, the MDCK-Sky was found to have an additional advantage of improved safety profiles compared to existing MDCK cell line.
“MFDS’s approval of SKYCellflu is a meaningful achievement for SK chemicals as well as a historical milestone in terms of national public health preparedness against pandemic influenza in Korea” said Dr. Mahnhoon Park, CEO of SK chemicals. Dr. Park also added “We are also in the final stage of phase 3 clinical trial for a quadrivalent seasonal influenza vaccine using the same technology, for which we have similar course of plan as SKYCellflu.”
SKYCellflu will be produced at SK chemicals’ vaccine production facility, also known as “L House”, located in Andong, Korea. Its customized single-use and multi-modular vaccine manufacturing systems provides greater efficiency and flexibility for production of diverse vaccine types. With MFDS’s Good Manufacturing Practice (GMP) approval last August, SK chemicals will be entering commercial production of SKYCellflu and supplying the Korean market in 2015/2016 seasons. L House is also expected to become the production base for the company’s future vaccines, including the new pneumococcal vaccine, varicella vaccine and typhoid vaccines.
About SK chemicals
With the mission to become a global leading company to deliver total healthcare solutions, SK chemicals has been striving to develop vaccines that are much needed around the world. In March 2014, the company entered the collaboration on an innovative pneumococcal vaccine with Sanofi Pasteur, the world’s leading vaccine company. SK chemicals also was honored with a grant from the Bill and Melinda Gates Foundation for its collaboration with International Vaccine Institute (IVI) to develop a new typhoid conjugate vaccine in 2014.