Search results for "cho"

Article Viral Clearance Challenges in Bioprocessing
“This practice is not in full compliance with current guidelines, but some agencies have accepted this type of data for IND applications of mAbs [monoclonal antibodies] derived from CHO [Chinese hamst…

Article Application of Quality by Design to Viral Safety
The list of potential contaminants for a master cell bank derived from Chinese hamster ovary (CHO) cells with a documented history may result in a defined list of tests, but the potential contaminants…

Article Trends in BioPharma Approvals in 2013
In terms of expression systems used, a total of eight of the products approved are expressed in mammalian cell lines (seven in CHO cells, one in Sp20), six are produced in yeast-based systems, four in…

Article Bioprocessing Advances in Vaccine Manufacture
In contrast, stainless-steel bioreactor-anchored facilities require costly and complex infrastructure, which further includes complex piping, including steam used for sterilizing stainless-steel equip…

Article Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012. In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…

Article Addressing the Challenges in Downstream Processing Today and Tomorrow
During development of an early-phase purification process for an acidic Fc-fusion protein expressed in a CHO cell culture system, it was determined that the protein displayed a range of 24–100% activi…

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