# Post-licensure vaccine services

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/9439690e-dbaa-49bb-9937-e2d8fce9579c
Type: Detailed Guide
Published: May 19, 2024
Updated: July 16, 2024

> The Vaccine Development and Evaluation Centre (VDEC), a core component of the UK Health Security Agency (UKHSA) based at Porton Down, provides specialized support for vaccine and therapeutic development. As this document is a services overview rather than an audit report, it does not list specific inspection dates or violations; however, it outlines the stringent regulatory framework under which VDEC operates, specifically Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). The facility assists partners in industry, academia, and government through every stage of development, with a particular focus on the post-licensure phase to ensure ongoing product safety and efficacy. Key service offerings include supporting the annual UK influenza vaccine batch release, conducting immunogenicity and antisera studies for Phase IV clinical trials, and providing molecular surveillance. Additionally, VDEC performs batch release testing for licensed vaccines, develops potency tests for developmental products, and conducts stability studies. By maintaining these high-standard laboratory services, VDEC plays a critical role in the regulatory pipeline. Organizations seeking to leverage these capabilities for vaccine evaluation and release are encouraged to contact the UKHSA to initiate collaboration and ensure their products meet necessary safety and quality benchmarks.

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The Vaccine Development and Evaluation Centre ( VDEC ) supports scientists at every stage of the vaccine and therapeutic medicine development process including in the post-licensure phase. Work with VDEC We work with industry, academia and government. Contact UKHSA today to see how we can help you. Get in touch What we can offer VDEC currently supports the UK’s annual influenza vaccine batch release by offering a range of compliant studies, including to good laboratory practice ( GLP ) or good manufacturing practice ( GMP ) as appropriate. These include: phase IV study support, including immunogenicity and antisera studies sero and molecular surveillance support batch release testing for licensed vaccines the development of potency tests to support vaccine release plus release of developmental vaccines stability studies Equipment at our Porton Down laboratory The post-licensure phase ensures that vaccines continue to be safe and effective.