GMP Compliance for Production of CB.Hep-1 Monoclonal Antibody as a Biological Reagent - - BioPharm International

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GMP Compliance for Production of CB.Hep-1 Monoclonal Antibody as a Biological Reagent

The positive results obtained during inspections carried out by our regulatory entity, Center for State Control of Drug Quality (CECMED), and the recent WHO inspection demonstrate that we have achieved a product of quality that fulfills the GMP. By keeping in mind all these requirements and by applying GMPs we have achieved the manufacture of a quality antibody for human use.

Biunayki Reyes Díaz, BSc.,and his colleagues listed, participated in the completion of this article and the work that supports it. Mr.Reyes Díaz, is the corresponding author.He and his colleagues currently work at: Monoclonal Antibody Division, Development Biotechnological Unit, Center for Genetic Engineering and Biotechnology Ave.31 e/ 158 y 190,Playa Cubanacan P.O.Box 6162, Havana 10600, Cuba Fax: 53.7.271.3208;

This article first appeared in J. GXP Compliance, Vol.9, No.3 (2005), pp 52-61.

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