Absence of genotoxic effects after exposure of mammalian cells to the recombinant human bone morphogenetic protein 2 (BMP‐2) prepared from E. coli

Abstract

AbstractRecombinant human bone morphogenetic protein 2 (rhBMP‐2) has been widely employed for the induction of bone growth in animal models and in clinical trials. Since rhBMP‐2 is commercially available only to a very limited extent, we have prepared our own recombinant material for the current testing and for future applications. As yet, no toxicological data on rhBMP‐2 has been reported to the knowledge of the authors. Therefore, it was considered necessary to apply the in vitro‐micronucleus assay to our preparation to monitor a possible genotoxic effect. A total of approximately 24500 nuclei from V79 Chinese hamster cells and more than 40000 nuclei from human amniotic fluid fibroblast‐like (AFFL) cells were screened for the frequency of micronuclei following incubation with 3‐300 nM rhBMP‐2, which covers the concentration range from initial biological activity to the begin of a maximal response in MC3T3‐E1 cells. It can be concluded from the results that our preparations of recombinant human BMP‐2 prepared in E. coli do not cause DNA damage in the concentration range tested.