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Medicines & Healthcare products Regulatory Agency
The National Institute for Biological Standards and Control

Confidence in biological medicines

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  • Biotherapeutics

Biotherapeutics

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

Control

We perform batch release testing, primarily of blood-derived products, in line with UK law. We also assess new products, perform non-EU batch release for various organisations (including foreign control authorities) and monitor released products.


Standardisation

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.

Research

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.


Our sections

The Biotherapeutics division is divided into five scientific sections:


Endocrinology



Cytokines and Growth Factors 

                            


Haemostasis

         

Molecular Immunology

  • Therapeutic immunoglobulins and allergens
  • Albumin solutions 
  • Blood cell and platelet immunology
  • Monoclonal antibodies 

Cellular Immunology

  • Pyrogenic pro-inflammatory activities
  • Immunotoxicology
  • Flow cytometry reference materials
 
Section leaders

Dr Chris Burns, Head of Division and Endocrinology
Dr Meenu Wadhwa, Cytokines and Growth Factors
Dr Anthony Hubbard, Haemostasis
Dr Sandra Diebold, Cellular Immunology
Dr Simon Hufton, Molecular Immunology

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