Control Testing of Biological Medicines

Biological substances used in healthcare include viral and bacterial vaccines, products derived from human blood, monoclonal antibodies, hormones, cytokines and growth factors. They have made a major and increasingly important contribution to medicine and public health and have brought radical improvements in the prevention and treatment of disease throughout the world..

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

Biological medicines and vaccines are usually very complex materials. 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, independently from the manufacturers, 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 (OMCL), NIBSC performs this function through the EU Official Control Authority Batch Release (OCABR) testing process. Other medicines control activities include assessment of new products, non-EU batch release, and product monitoring of released products. Products are also evaluated under the Centrally Approved Products (CAP) testing scheme organised by the European Directorate for the Quality of Medicines and Healthcare. Control work conducted by NIBSC is carried out in compliance to ISO/IEC 17025, with independent accreditation by UKAS.

NIBSC works closely with the EU OMCL network and regulatory authorities regarding development of policies and processes for batch release assessment and related activities. Associated research activities are conducted to underpin control work. These allow rapid responses to unexpected safety and/or efficacy problems which can sometimes occur with biological medicines. 

Our aim is 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.