Biotherapeutics

Monoclonal Antibodies

Our team carries out research focused on monoclonal antibody structure and function. We aim to understand why certain antibodies can lose efficacy through processes such as redox mediated modifications in vivo, adverse immune responses or changes in antigenic sequences. We apply cutting edge antibody technologies in our research supporting the discovery of nanobodies and display libraries with broad applications including diagnostics, therapeutics and as research tools for immunoassays. We have isolated numerous well-characterised nanobodies to various pathogens, such as influenza and SARS-CoV-2, which are available for licensing opportunities (find out more here).

We also develop reference materials to support the standardisation of assays that measure potency and immunogenicity of therapeutic monoclonal antibodies and their biosimilars, in close collaboration with WHO and major pharmacopoeias. This includes contributions to the development of both written standards (e.g. biosimilar guidance, product monographs) and reference materials for measurement of biological activities, therapeutic drug monitoring and anti-drug antibodies.

Recent publications

Susceptibility of broad reactivity nanobodies to resistance mutations in the S2 domain of SARS-CoV-2 predicted by yeast display deep mutational scanning

The first WHO reference panel for Infliximab anti-drug antibodies: a step towards harmonizing therapeutic drug monitoring

For more information contact simon.hufton@mhra.gov.uk or meenu.wadhwa@mhra.gov.uk.

Immunotherapy

The Immunotherapy group develops innovative, human‑relevant assays and models to strengthen preclinical evaluation of immune safety and efficacy. Our work includes predictive in vitro platforms and humanised mouse models to support the assessment of immune‑related risks. We also develop well‑characterised reference materials to support assay performance and comparability as well as cell‑based immunophenotyping, as well as flow cytometry–based potency assays for mRNA vaccines, biotherapeutics and cell therapies, with a focus on cancer immunotherapy.

Through international collaborative studies and partnerships with metrology organisations worldwide, the group helps build confidence and traceability in immune cell measurement.

Recent publications

Evaluation of a Reference Antibody Panel for prediction of Cytokine Release in Humanised Mouse Models in vivo

For more information contact sandrine.vessillier@mhra.gov.uk.

Cellular Immunology

The Cellular Immunology team develops advanced cell‑based and serological reference materials, as well as bioanalytical methodologies, to support research and regulatory workflows across immunology, regenerative medicine, and clinical flow cytometry. Our group engages with internal and external stakeholders to facilitate robust evaluation of the safety, potency, and functional attributes of therapeutic products, including biologics and advanced therapy medicinal products (ATMPs) and in vitro diagnostic (IVD) technologies.

For more information contact: cellular.immunology@mhra.gov.uk.

Immunohaematology

Our team leads and collaborates on research focused on platelet biology, immunology, and functional characterisation. Our work spans platelet alloantibody responses, glycoprotein phenotyping, platelet activation pathways, and the evaluation of emerging platelet products, including stem-cell-derived platelets. These studies encompass donor-derived platelets, clinical samples, and engineered platelet products.

We utilise a range of advanced analytical and functional platforms, including multiparameter flow cytometry, platelet activation assays, glycoprotein expression profiling, and comprehensive functional platelet testing to investigate platelet phenotype, function, and immune interactions. Through this work, we aim to better understand platelet behaviour in health and disease and to support the development of innovative therapeutic approaches.

For more information please contact immunohaematology@mhra.gov.uk.