From laboratory to clinic: the development of an immunological reagent.
Access to a wide range of high quality and increasingly sophisticated reagents and equipment has underpinned the great surge of knowledge in basic immunology and the growing interest in clinical immunointervention. In this article, the first in an occasional series on immunological research and development in industry, Sue Bright and colleagues outline the key steps in a development programme to take a humanized monoclonal antibody into the clinic. The procedures involved in developing such reagents, particularly for clinical use, are long and require considerable ingenuity and scientific creativity.
Bright
S
S
Celltech Limited, Slough, UK.
Adair
J
J
Secher
D
D
D000230:Adenocarcinoma / Q000276:immunology; D000818:Animals; D000911:Antibodies, Monoclonal / Q000235:genetics / Q000302:isolation & purification / Q000493:pharmacokinetics / Q000633:toxicity; D000912:Antibodies, Neoplasm / Q000235:genetics / Q000302:isolation & purification / Q000493:pharmacokinetics / Q000633:toxicity; D000951:Antigens, Neoplasm / Q000276:immunology; D002460:Cell Line; D006224:Cricetinae; D003412:Cricetulus; D005069:Evaluation Studies as Topic; D005260:Female; D005347:Fibroblasts; D005803:Genes, Immunoglobulin; D005813:Genes, Synthetic; D006023:Glycoproteins / Q000276:immunology; D006801:Humans; D006825:Hybridomas / Q000276:immunology; D007074:Immunoglobulin G / Q000096:biosynthesis / Q000235:genetics / Q000302:isolation & purification; D051379:Mice; D009374:Neoplasms, Experimental / Q000175:diagnosis / Q000628:therapy; D010053:Ovary; D015202:Protein Engineering; D011993:Recombinant Fusion Proteins / Q000235:genetics / Q000302:isolation & purification / Q000493:pharmacokinetics / Q000633:toxicity
D000911:Antibodies, Monoclonal; D000912:Antibodies, Neoplasm; D000951:Antigens, Neoplasm; D006023:Glycoproteins; D007074:Immunoglobulin G; D011993:Recombinant Fusion Proteins