Biocompatibility of adenoviral vectors in poly(vinyl chloride) tubing catheters with presence or absence of plasticizer di‐2‐ethylhexyl phthalate

Abstract

Adenoviral (Ad) vectors feature attractive characteristics for gene therapy of a wide variety of diseases. In many cases, the Ad vector must be administered using catheters and other plastic medical devices. Although poly(vinyl chloride) is one of the most frequently used catheter materials, it is relatively rigid and requires the addition of a plasticizer such as di-2-ethylhexyl phthalate (DEHP) to increase its flexibility. In this study, we demonstrated that exposure to a DEHP-containing catheter decreased the infectivity of Ad vectors but not the total particle number of the vector. Loss of Ad vector infectivity was directly related to the time of exposure to the DEHP-containing catheter, but it was not due to simple leaching of the chemical from the plastic. The loss of Ad vector infectivity could be prevented by preflushing the tube with albumin. Careful consideration of the compatibility between gene therapy vectors and medical delivery devices will be critical to the success of human gene therapy applications.

Metallocene based polyolefin: a potential candidate for the replacement of flexible poly (vinyl chloride) in the medical field

“…Kim et al reported the effect of DEHP on platelet adhesion and aggregation 9. Roberto Bilbao et al demonstrated an adverse effect on Ad vector infectivity and it raised a new concern for the use of DEHP/PVC products for human gene therapy 10. Moreover, DEHP has been shown to cause hepatic, renal, and reproductive complications in rodents 11.…”