Compendial Quality & Function Testing of Fetal Bovine Serum
Heather Beyer, Ph.D., Manager, Viral Safety Testing Services
Andrew D. Schaefer, Principal Scientist/Group Leader, Biologics Raw Material Testing
Fetal Bovine Serum (FBS), as a byproduct of the cattle industry, is one of the preferred animal sera for cell culture proliferation. With an abundance of protein, growth factors, enzymes and other chemical components, and a characteristically low or absent concentration of interfering antibodies, FBS is ideal for promoting cell health and growth.
In an effort to provide guidance and standards for use, the European Pharmacopeia (EP) and US Pharmacopeia (USP) have released general Quality Attributes and Functionality Tests for FBS. The quality attributes tests provide standards to ensure consistency in protein content, hemoglobin level, pH, osmolality, IgG, species identification, and electrophoretic profile. The functionality testing outlined by the compendia can be performed with specified cell lines, comparing cell growth in test sera supplemented media versus reference sera supplemented media. However, in many cases, clients will favor establishment of their own user-defined functionality assays, to ensure that test sera supports appropriate growth of their own cell line.
Eurofins Lancaster Laboratories, Inc. (ELLI) has established a broad array of physical, chemical, electrophoretic, and immunochemical techniques for determination of quality attributes of sera. With substantial experience and expertise in cell culture needs, ELLI can support serum functionality testing, including collaborative design and execution of user-defined testing. Eurofins Lancaster Laboratories’ vast capacity and extensive capabilities can provide clients with rigorous quality attribute testing and critical functionality testing to ensure fast-growing healthy cell lines, making animal sera a practical quality controlled means for cell culture enhancement.