CORE--PRODUCTION OF HUMAN ANTI-COCAINE MONOCLONAL ANTIBODY

University Of Cincinnati, Cincinnati OH

Investigators

Linked publications & trials

Abstract

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.