The National Insitute for Biological Standards and Control (NIBSC) is a centre of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) which is an executive agency of the UK Department of Health. NIBSC is the UK Official Medicines Control Laboratory and a WHO International Laboratory for Biological Standardisation. Operating at the interface between scientific research, product development, regulation and policy, NIBSC's mission is to safeguard and improve public health through assuring the quality of biological medicines and provision of biological reference materials.
Role of NIBSC within the VAC2VAC project
NIBSC will be involved in the development and characterisation of in vitro methods and will lead on development of immunochemical methods. NIBSC will also provide expert advice for validation of methods and regulatory acceptance of non-animal methods.
The group at NIBSC involved in the VAC2VAC project is responsible for the control testing of diphtheria and tetanus vaccines and antitoxins and the development of biological standards for these products. Research interests include development and validation of in vitro immunochemical and cell based assays for the characterisation of vaccines, toxins and antitoxins.
NIBSC representatives for VAC2VAC are Dr. Paul Stickings, Dr. Thea Sesardic, and Laura Coombes.