SK Bioscience was granted another Prequalification Certificate (PQ) after having been trying since May of last year for its cell-cultured quadrivalent vaccine, Skycellflu.
Skycellflu is the first cell-cultured quadrivalent vaccine that treats four types of influenza viruses to receive a prequalification certificate as said by SK Bioscience.
The vaccine was developed using a state-of-art sterile incubator, antibiotics and preservatives are not requried in its manufacturing process.
Because fertilized egg is not used in its manufacturing process, treatment is deemed safe for those who are allergic to eggs or antibiotics.
The PQ certification validates the safety, quality, manufacturing and the efficiency of the vaccine.
According to SK Bioscience, it usually takes a long period to receive approval from the World Health Organization (WHO).
Companies are to pass the rigorous process of revision of clinical and quality documents, sample quality testing, factory good manufacturing practice implementations, and management level inspection.
However, SK Bioscience was able to reduce the time taken to receive the approval by just 10 months.
This PQ certification will allow SK Bioscience to participate in international bids organized by UN agencies.
Mr. Ahn (CEO) said that SK Bioscience plans to aggressively take part in the global market as the paradigm of flu vaccine shifts and because they have also successfully secured three PQ certifications in a single year, including trivalent flu vaccine and chickenpox vaccine.