The purpose of Core C is to produce sufficient amounts of the human monoclonal antibodies who have high specificity and affinity for cocaine to conduct the animal trials of Project 2. Then the Core will provide for the production, purification and preparation of one human IgG(k) anti- cocaine mAb which is suitable for use in human clinical trials. Based upon the 'in vitro' and 'in vivo' animal data generated in Projects 1 and 2 one mAb will be selected for safety testing and large scale production that meets the FDA requirements for human use. Personnel from GenPharm International and Medarex Incorporated will combine their expertise in order to ensure that at least 225 grams of antibody is produced in accordance with the FDA's Good Manufacturing Practice (GMP) regulations. In addition GenPharm International has recently been acquired by Medarex, Inc., and will continue to function as a wholly owned subsidiary. This merge is beneficial to both companies, and as a consequence GenPharm International how has access to Medarex's production facilities which will result in substantial cost savings compared to an outside contract manufacturer. This is critical because of the large amounts of antibody that may be needed for this SPIRCAP project.

National Institute of Health (NIH)
National Institute on Drug Abuse (NIDA)
Research Program--Cooperative Agreements (U19)
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University of Cincinnati
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Norman, Andrew B; Tabet, Michael R; Norman, Mantana K et al. (2007) A chimeric human/murine anticocaine monoclonal antibody inhibits the distribution of cocaine to the brain in mice. J Pharmacol Exp Ther 320:145-53
Norman, Andrew B; Tsibulsky, Vladimir L (2006) The compulsion zone: a pharmacological theory of acquired cocaine self-administration. Brain Res 1116:143-52
Tsibulsky, Vladimir L; Norman, Andrew B (2005) Real time computation of in vivo drug levels during drug self-administration experiments. Brain Res Brain Res Protoc 15:38-45
Paula, Stefan; Tabet, Michael R; Farr, Carol D et al. (2004) Three-dimensional quantitative structure-activity relationship modeling of cocaine binding by a novel human monoclonal antibody. J Med Chem 47:133-42
Norman, Andrew B; Buesing, William R; Norman, Mantana K et al. (2004) The self-administration of WIN 35,428 and cocaine: comparisons of satiety threshold and elimination half-life in rats. Eur J Pharmacol 483:281-7
Cabovska, B; Norman, A B; Stalcup, A M (2003) Separation of cocaine stereoisomers by capillary electrophoresis using sulfated cyclodextrins. Anal Bioanal Chem 376:134-7
Paula, Stefan; Tabet, Michael R; Keenan, Susan M et al. (2003) Three-dimensional structure-activity relationship modeling of cocaine binding to two monoclonal antibodies by comparative molecular field analysis. J Mol Biol 325:515-30
Norman, Andrew B; Welge, Jeffrey A; Tsibulsky, Vladimir L (2002) Characterization of the distribution of the cocaine priming threshold and the effect of SCH23390. Brain Res 946:253-61
Norman, A B; Tsibulsky, V L (2001) Satiety threshold regulates maintained self-administration: comment on Lynch and Carroll (2001). Exp Clin Psychopharmacol 9:151-4; discussion 160-2
Tsibulsky, V L; Norma, A B (2001) Satiety threshold during maintained cocaine self-administration in outbred mice. Neuroreport 12:325-8

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