Reference biomaterials for biological evaluation.

The variability associated with most of the biological evaluation studies is relatively large and hence experimental controls are frequently employed to ensure that the results are reliable. These experimental controls, either positive or negative controls, could be considered as reference materials in the context of biological evaluation. Currently, reference biomaterial needs across the world are not addressed satisfactorily. Affordability and lack of availability of certified reference materials necessitates the development and the use of laboratory developed RMs. A well defined characterization strategy is essential for the successful development of in house reference materials. This article provides an overview of the current international status in the area of reference biomaterials and enumerates the steps involved in the development of an in house reference material. The production and characterization of commercially pure titanium pins for use as negative controls during muscle implantation studies is presented as a case study.