# Pre-clinical vaccine evaluation

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/89f3f781-096e-4793-9e13-c0ac8140587f
Type: Detailed Guide
Published: May 19, 2024
Updated: January 10, 2025

> The Vaccine Development and Evaluation Centre (VDEC), a division of the UK Health Security Agency (UKHSA), provides comprehensive pre-clinical evaluation services to support vaccine and therapeutic development. Operating within a robust regulatory framework, the center maintains an enhanced quality management system compliant with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards. Their facilities are accredited for high-containment research at Biosafety Levels 3 and 4, adhering to the Advisory Committee on Dangerous Pathogens (ACDP) and Specified Animal Pathogen Order (SAPO) safety requirements. VDEC specializes in animal modeling, ranging from small rodents to non-human primates, and is currently focused on high-priority pathogens including avian influenza (H5N1), Respiratory Syncytial Virus (RSV), and antimicrobial-resistant Pseudomonas aeruginosa. The center also utilizes innovative 'organ-on-a-chip' technology to refine immune response studies and reduce animal reliance. As this document serves as a descriptive overview of VDEC’s capabilities and current initiatives, it does not detail specific inspection dates, regulatory violations, or mandatory corrective actions. Instead, it highlights the center's role in global health efforts, such as the 100 Days Mission, and invites collaboration from industry, academia, and government partners to ensure data integrity for regulatory submissions.

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The Vaccine Development and Evaluation Centre ( VDEC ) supports scientists at every stage of the vaccine and therapeutic development process. VDEC ’s pre-clinical evaluation team provides animal modelling capability to support the vaccine development pathway. This creates a safe and controlled environment to test new vaccines before starting human trials. Speak to our pre-clinical evaluation team We work with industry, academia and government. Contact UKHSA today to see how we can help you. Get in touch What the pre-clinical evaluation team does We offer 3 main capabilities. These are: an ability to handle a wide range of species; from small rodents up to non-human primates ( NHP ), with the latter sourced from UKHSA -owned rhesus and cynomolgus macaque colonies accreditation to perform infectious disease research at high-containment biosafety levels ( BSL ) levels 3 and 4, for both operator (Advisory Committee on Dangerous Pathogens: ACDP ) and environmental (Specified Animal Pathogen Order: SAPO ) protection an enhanced quality management system suitable for good laboratory practice ( GLP ) and good manufacturing practice ( GMP ) compliance These capabilities support the generation of data from early-stage experiments through to pivotal studies. They assure data quality and integrity for submission to regulatory agencies where required. Current priorities We are currently establishing pre-clinical models and assays to assess the efficacy of vaccines and antivirals against circulating strains of highly pathogenic avian influenza (H5N1). We are also developing: assays and small animal models for respiratory syncytial virus ( RSV ), to enable evaluation of deployed vaccines and to assess future products a respiratory infection model for antimicrobial resistance ( AMR ) priority pathogen Pseudomonas aeruginosa and will use this model to analyse therapeutic regimens versus standard care antibiotic therapy Case study: ‘organ-on-a-chip’ See how the pre-clinical team use ‘organ-on-a-chip’ models to study infections and immune responses, aiming to improve vaccine testing and reduce reliance on animal research. VDEC Pre-clinical team helped to develop organ-on-a-chip to protect human health Microphysiological systems: how ‘organ on a chip’ technology is changing science How we work with partners We engaged with internal and external stakeholders to identify priorities for pandemic preparedness and tackling AMR . We will also continue to work closely with organisations such as CEPI to develop models and assays for priority pathogens in support of the 100 Days Mission . Scientist conducting an assay