by Charles L. Soliday, PhD, Lisa Krivokopich, and Victoria Rothwell, PhD
Volume 3, Issue 1 (January/February 2004)
Validating the safety of biological preparations requires thorough testing for contamination by adventitious agents. Utilizing mammalian cell cultures to produce recombinant proteins as biopharmaceuticals requires testing for viral contamination. The polymerase chain reaction (PCR) may be employed to specifically detect the presence of viral DNA or RNA with great sensitivity. PCR assays are particularly useful for the qualification of recombinant cell banks. Regulatory agencies recommend that mammalian cell banks be tested for a variety of possible human viral contaminants. In most cases the cells used to produce the cell bank have been previously analyzed for viral contamination. The use of PCR for the detection of viruses in the final banked cells can alleviate the need for difficult, costly, and time-consuming infectivity assays. In some cases the relevant viruses cannot be cultured, eliminating the ability to perform infectivity assays. The PCR assay can provide a sensitive and specific method for detection of viral contamination when standard infectivity assays are unsatisfactory…
Citation:
Soliday CL, Krivokopich L, Rothwell V. Improved Analysis of PCR Viral Detection Using Chip-based Capillary Gel Electrophoresis. BioProcess J, 2004; 3(1): 49-54.