Retrovirus-like particles (RVLPs) are present in Chinese Hamster Ovary (CHO) cell bulk culture. They resemble tumorigenic retroviruses and thus, pose a theoretical safety concern. Clearance of RVLP in the downstream process is required by regulatory agency for worldwide product market registration. As an alpha tester, we evaluated a high titer RVLP stock and reagents for detection and quantitation of RVLP by qPCR. The data show high titer RVLP stock may be used to evaluate the viral clearance for the downstream process and provide further support to use qPCR technology in quantitating RVLP levels.
Learning Objectives:
Upon completion, participant will be able to gain first hand knowledge of the use of soon to be available reagents in the market for RVLP clearance assessment.
Upon completion, participant will have a better understanding of whether they would need a CHO culture specific primer set for RVLP detection.
Upon completion, participant will be able to reassess their RVLP clearance strategy.
