Advanced Biomaterials and Devices in Medicine
December 2014, Volume 1, Issue 1, pp 38-45
Essential criteria that must be met by novel biomaterials prior to further in vitro and in vivo biological evaluation
REPAIR-Lab, Institute of Pathology, University Medical Centre of the Johannes Gutenberg University, Mainz, 55131 Germany
* Corresponding author: Dr. Ronald E. Unger, e-mail: firstname.lastname@example.org
The development of biomaterials for use in humans has expanded at an ever increasing rate in the last 20 years. It is essential for the further evaluation of efficacy in in vitro model systems and for use in animal or eventual human patients that the materials used are sterile, free of cell-toxic compounds and free of endotoxin. Many of the biomaterials are being developed in university or small laboratories without access to large cell biology laboratories that will have the facilities or methodology to routinely screen samples to evaluate them for these factors. In this study three methods are described for rapidly testing samples for sterility, cell toxicity and the presence of endotoxin that only require equipment normally found in the most basic of cell biology laboratories. Not only are these methods useful for screening the end product, but they can also be used at any step of the manufacturing process to determine the origin and location of possible contaminations.
Keywords: biomaterial, nanoparticle, endotoxin, sterility, cell toxicity, biocompatibility testing, nanotoxicity