In fulfilment of the NIBSC’s function as a National Control Laboratory, the Division of Bacteriology carries out scientific testing to confirm that bacterial vaccines, therapeutic antitoxins and toxins used in human medicine meet their licence specifications, providing independent assurance of quality and safety. The Division also tests vaccines for the World Health Organisation (WHO) Prequalification Programme World Health Organisation (WHO) prequalification Programme to help ensure the quality of medicines purchased by United Nations (UN) agencies for use in low and middle income countries.
We produce a wide range of bacteriological standards and reference materials. They are principally to ensure consistency in the biological assays used to test the quality of bacterial products. For a comprehensive list see the online catalogue.
A programme of applied research which underpins our statutory product testing and standardisation functions. Our goal is to develop new or improved ways of ensuring the quality of bacterial medicinal products through a thorough understanding of how they work and the properties that contribute to their safety and efficacy. Our research and development work often involves collaborations with national and international researchers and organisations.
The Division of Bacteriology’s research programme includes the following broad areas:
- the reduction, refinement and replacement - so-called 3Rs - of animal-based methods
- preclinical assessment of vaccine candidates and delivery systems
- antigenic diversity
- vaccine stability
- proteomics of complex vaccines
- reactogenicity and proinflammatory responses to vaccines