title: Removal of endogenous retrovirus-like particles from CHO-cell derived products using Q sepharose fast flow chromatography.
abstract: Retrovirus-like particles (RVLPs) that are expressed during the production of monoclonal antibodies in Chinese hamster ovary (CHO) cell cultures must be removed during product recovery. Anion exchange chromatography (AEX) performed in product flow-through mode, a common component in the purification of monoclonal antibodies, has been shown to provide robust removal of a related retrovirus model, but it's ability to remove the actual RVLP impurities has not been directly investigated. We have determined the ability of a typical Q sepharose process to remove actual CHO RVLP impurities. Using small scale experiments with three model antibodies, we observe that this AEX process is capable of effectively removing both in-process and spiked RVLPs from different feedstocks containing different mAb products. In addition, we show that this AEX process also achieves a similarly high degree of RVLP removal during large scale manufacturing operations.
authors.affiliation: Process Research and Development, Late Stage Purification, Genentech Inc., One DNA Way, South San Francisco, CA 94080, USA.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Strauss
authors.forename: Scott
authors.initials: S
authors.lastname: Lute
authors.forename: Kurt
authors.initials: K
authors.lastname: Brorson
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Blank
authors.forename: Qi
authors.initials: Q
authors.lastname: Chen
authors.forename: Bin
authors.initials: B
authors.lastname: Yang
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000737:chemistry / Q000302:isolation & purification*; D016466:CHO Cells; D002852:Chromatography, Ion Exchange / Q000379:methods*; D006224:Cricetinae; D003412:Cricetulus; D004340:Drug Contamination / Q000517:prevention & control*; D020077:Endogenous Retroviruses / Q000737:chemistry / Q000302:isolation & purification*; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000302:isolation & purification*; D011485:Protein Binding; D012685:Sepharose / Q000737:chemistry
chemical_list: D000911:Antibodies, Monoclonal; D004364:Pharmaceutical Preparations; D012685:Sepharose