Over the course of 25 years, the potential therapeutic value of biopharmaceuticals has been realized. One component of the overall safety paradigm for these therapeutic agents is the evolution and execution of viral testing, and it has been an exciting time for those of us involved in it. Participating in several of the viral contamination events that have occurred during this quarter century has proven to be particularly enlightening. Most involved hamster (especially Chinese hamster) cell substrates. This has been somewhat surprising given that biopharmaceuticals are produced in cells derived from a number of different animal species. More recently, however, viral contaminations involving human and monkey cell substrates have also been reported. While considering risk to biopharmaceutical manufacturing processes, it is not unusual to hold the belief that a mammalian production cell is riskier, although this is not appropriate. Even processes involving bacterial fermentation are at risk of viral contamination by the bacteriophage. These agents are not believed to represent a patient safety risk but they can certainly wreak havoc with manufacturing processes utilizing bacterial production cell substrates. Any discussion of viral risk to biopharmaceutical manufacturing should therefore include both cell culture and bacterial fermentation processes, and their associated viral contaminants…
Tag: <span>bacterial fermentation</span>
The gram-negative bacterium, Escherichia coli, has a long history in the world of laboratory and industrial processes due to its ease of manipulation and well-understood genome. It is widely cultured under aerobic conditions. High cell density cultivation of E. coli is a powerful technique for the production of recombinant proteins. Indeed, 30% of the FDA-approved biopharmaceuticals on the market are produced in E. coli. An Escherichia coli fermentation run conducted using the Eppendorf BioFlo® 320 bioprocess control station achieved high cell density at 12 hours, as determined by a maximum optical density (OD600) measurement of 215.2. The weights of dry and wet cells were also measured…