UKHSA is GLP accredited and well prepared to offer their considerable expertise in:
- Development and validation of biological assays including functional, neutralization, and cell-based assays
- Development and validation of novel assays including Host Cell Protein detection and enzymatic activity assessment
- Development and validation of assays to evaluate cellular and memory immune responses in both clinical and non-clinical samples
- Worldwide provisioning of specialty serology services including tetanus, diphtheria, Hib, and pertussis (PT, Fim2+3, FHA, and Pertactin) all in compliance with GCLP
- Batch releasing and stability testing of vaccines (including seasonal flu) and therapeutics worldwide including U.K., EU, and U.S.
- R&D activities in infectious diseases, up to and including BSL-3 and BSL-4, including rare and exotic pathogens and those identified as potential bioterrorism agents
- International collaboration including academia, industry, charities, and governments
UKHSA provides extensive experience in the development and application of animal models (mouse, guinea pig, ferret, rabbit, and NHP) to perform studies such as pathogenesis, transmission, immunogenicity, efficacy, and potency.
In particular, to conform to U.K. law, all in vivo activities are conducted in BSL-2, BSL-3, or BSL-4 facilities by a dedicated team of animal technicians, a Named Veterinary Surgeon (NVS), two registered Veterinary Pathologists, and several Named Animal Care Welfare Officers. Examples of animal models available at UKHSA include influenza, TB, Ebola, Lassa, Crimean-Congo hemorrhagic fever, monkeypox, anthrax, Middle East respiratory syndrome, chikungunya, Zika, C. difficile, Burkholderia pseudomallei (aka pseudomonas pseudomallei), Coxiella burnetii, et al.
UKHSA has a proven track record in assay development, qualification, and validation, plus the execution of these assays under GxP (clinical, laboratory, and manufacturing) compliance for product and process characterization, release and stability, and in serological assessment of sera samples from clinical trials. We also provide consultancy on method feasibility, development, validation, and technology transfer.