Adventitious agents from animal-derived raw materials--a method of risk assessment

Abstract

The use of animal-derived raw materials in biopharmaceutical manufacture has a long history. On a risk/benefit basis the use of these raw materials has certainly been beneficial. With proper precautions animals will continue to be the source of raw material for many years to come. As scientific sophistication increases, continuing examination of animal-derived raw material sourcing is important. Even as biopharmaceutical production has made significant progress so has the quality and safety of available animal-derived supplements. It is now possible to perform a reasonable assessment of risk as it relates to adventitious agents. An easy-to-use, preliminary risk-assessment exercise will be discussed. It will allow users of animal-derived raw materials to make more informed decisions regarding the need and type of pre-use processing before the final risk/benefit analysis. Areas to be assessed include geographical origin, age and species of animal, method of harvesting, and anatomical origin of the material.