The Division of Biotherapeutics has a broad remit covering all biological products with a therapeutic potential in humans, excluding vaccines. Our core functions of standardisation and product control testing are underpinned by a programme of applied research.
What we do
We perform batch release testing, primarily of blood-derived products, for the European market. We also assess new products, perform non-EU batch release for various organisations (including foreign control authorities) and monitor released products.
We produce standards and reference reagents including World Health Organisation (WHO) International Standards. These support the calibration of assays used to determine biological potency or identity of biotherapeutics, assay characterisation, as well as diagnostic and research applications.
Our research activities help to maintain our expertise in the standardisation and control of biotherapeutics and allow us to respond rapidly to unexpected safety and/or efficacy concerns. We’ve previously been involved in responses to incidents such as contaminated heparin, the first-in-man trial with monoclonal antibody TGN1412
, thrombogenicity associated with intravenous immunoglobulin preparations and unwanted immunogenicity of biologicals.
The Biotherapeutics division is divided into five scientific sections: