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KMID : 1142220150100020111
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Regulatory Research on Food, Drug & Cosmetic
2015 Volume.10 No. 2 p.111 ~ p.115
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Standardization of Haemagglutinin Content Test for Influenza Vaccine
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Chang Seok-Kee
Kim Do-Keun
Chung Hye-Joo
Oh Ho-Jung
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Abstract
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Vaccines should be produced and managed in order that vaccine's quality is maintained consistently. Therefore, vaccine manufacturers should set the specification and test methods in each manufacturing step and it is necessary to do the quality control in accordance with this. Haemagglutinin (HA) content test has been used for many years as a potency test for influenza vaccines. Single radial immunodiffusion (SRID) assay is the most widely used method in the determination of HA content. HA antigen diffuses radially from the wells and reacts with specific antibody, producing a ring of precipitation in the agarose gel. The diameter of reaction ring surrounding wells is the estimate of the antigen content. Finally, HA content is determined by using statistical method (slope-ratio model) as compared with the standard. It is very important to standardize the test method for the quality control of biological products including vaccines. Thus, we standardized the HA content test through collaboration study with 10 institutions and tried to ensure the consistency, transparency and reliability for the quality control of influenza vaccines.
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KEYWORD
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influenza vaccines, haemagglutinin content test, single radial immunodiffusion assay, quality control
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