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Considerations for Manufacturing and Quality Control of Recombinant Vaccines

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The conventional live or killed vaccines, though quite successful, have a few shortcomings which make a chance to develope new kinds of vaccines1). For some reasons, new approaches are being considered for vaccine development, which are not based on the entire organism. These include recombinant vaccines, DNA vaccines, peptide vaccines and therapeutic vaccines. I will mainly focused on recombinant vaccines are created by utilizing bacteria or yeast to produce large quantities of a single viral protein. Up to now, recombinant
vaccines licensed in our country are hepatitis B vaccine and HPV vaccine. The success of the first VLP vaccine in humans, the yeast-grown HBV vaccine, was encouraging for the development of additional VLP vaccines. The subsequent successful immunization programs for HPV suggest that VLP made by expression of recombinant capsid proteins may be a platform technology for all non-enveloped viruses that emerge as candidates for vaccine protection2). I
will also mention a recent direction, namely, the development of recombinant virus vaccines as well as in manufacturing and quality control for recombinant vaccines according to related guideline published by KFDA.

저자정보

  • Dokeun Kim Viral Vaccines Team, Biologics Headquarters, Korea Food & Drug Administration

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