Regulatory expectations on the use of vaccine reference standards for maintaining product quality.

Last updated on 19-12-2023 by Wim Van Molle

Scientific poster, presentation or proceeding





Introduction – The manufacture of vaccines often involves complex processes requiring a strict control strategy at all steps. The Final Drug product should meet all requirements regarding safety and efficacy before its release to the market. The use of (international) reference standards or reference preparations plays a key role in assay validation and product qualification.      Challenges – Manufactures are sometimes faced with the challenge to select, produce and qualify suitable standards for their intended use. Ideally, international reference standards are d…

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