Regulatory and Legal Requirements for the Manufacture of Antibodies

Monoclonal antibodies are antibodies which have a defined single amino sequence, specificity and affinity. They can be obtained from immortalised hybridoma or B lymphocytes or by recombinant DNA technology. The development of these techniques has paved the way for the design and production of specific monoclonal antibodies with the requisite antigenic determinants for the treatment and diagnosis of a range of clinical indications.