Biological substances used in medicine are often very complex materials. They include bacterial and viral vaccines against diseases such as diphtheria, whooping-cough, meningitis, poliomyelitis, influenza, hepatitis, measles, mumps and rubella. They also comprise products derived from human blood such as clotting factors and immunoglobulins. In addition to these more traditional products, an increasing number of new 'high-tech' biological medicines are being produced by the latest techniques of genetics and molecular biology.

 

In order to ensure that these products are both safe and effective it is necessary to thoroughly evaluate their quality and biological activity. For many biologicals there is a legal requirement that each batch is examined and approved before release onto the market. Such 'control' or 'batch release' testing involves the review of manufacturing documentation and laboratory tests on the product itself. As the UK's Official Medicines Control Laboratory, NIBSC has performed this function for many years and continues to do so. Additionally the Institute is an European Official Medicines Control Laboratory (OMCL) for batch release testing of biological medicines onto the European market and to date is one of a few OMCLs to achieve independent accreditation for such work.

Our aim to maintain our position as a leading, influential and respected member of the European OMCL network carrying out batch release testing of products in areas of major public health impact.