Recombinant Protein Production Health And Safety Issues

In addition to being structurally and functionally analogous to the natural plasma-derived protein, purified recombinant proteins must be free of pathogenic organisms. Viral and bacterial contamination of human biopharmaceutical products produced in the blood or milk can be minimized by focusing prevention/eradication efforts on at least three levels of production: the transgenic animal donor, the medium in which the recombinant protein is produced, and the final product.[4] An initial key to minimizing the risk of contamination is to derive the transgenic donor animals from a source herd that is free from as many pathogens as possible. Maintenance of these animals in a closed facility, the implementation of strict monitoring procedures for various pathogens, and the use of animal husbandry practices that follow generally accepted practices (GAPs) and standard operating procedures should greatly reduce the entry of pathogens. Though quite costly, one can develop pathogen-free herds of transgenic livestock. Such a feat was recently achieved by introducing hysterotomy-derived transgenic piglets into an elaborate SPF barrier facility.[11] Diagnostic testing of this herd over the past 3 years in this facility had revealed the absence of 35 major and minor swine pathogens including PRRS, parvovirus, leptospira, parainfluenza, and Streptococcus suis.

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