Pre-Clinical Requirements for Biotechnology Derived Products

Abstract

A major concern about continuous cell lines is that tumor-inducing factors such as oncogenes or oncogenic viruses derived from these cell cultures might be imported with the product and lead to formation of a tumor in the recipient. Therefore, governmental agencies in many countries provided guidelines to manufacturers of cell culture products. These guidelines define appropriate testing to address the crucial issues involved in the production of biologicals in cell lines. These include general cell characterization, in vitro and in vivo tests for rodent and non-rodent viruses, retroviruses assays, tests for bacterial and mycoplasmal contaminants, final and bulk-final product tests and validation of the purification process for inactivation and/or removal of contaminants. This presentation will offer an overview of the current guidelines.