Roche Launches Iron and Phosphate Test Reagents for BioPharmas

By Gareth Macdonald and Dan Stanton

- Last updated on GMT

Roche launches iron and phosphate test reagents
Roche launches iron and phosphate test reagents
Roche has added iron and phosphate to the list of metabolites BioPharmas can detect and quantify using its process analytics technology.

The two new reagents - which were launched by Roche’s diagnostics division earlier this month – are ready to use liquids for use with the Swiss drugmakers’ range of Cedex Bio colorimetric instruments, which are used during the fermentation process to monitor and optimise growth conditions.

Spokeswoman Dr Claudia Schmitt told that iron and phosphate concentration are relevant parameters in the upstream process for both mammalian and microbial cell lines, adding that “for trace elements like Iron it is essential to maintain the optimal balance throughout the fermentation process.”

“The new parameters are of particular importance for the optimization of process development and monitoring of bio-pharmaceutical production based on fully chemically defined media.”

The Science

Dr Schmitt explained the process using the iron test as the example. “First the complexed iron is liberated at low pH, Fe(III) ions are then reduced to Fe(II) ions by ascorbate.

“These Fe(II) ions react with FerroZine to form a colored complex. The absorbance measured at 552 nm is directly proportional to the iron concentration of the sample​.”

She added that the ability to test for iron and phosphate concentration using a single system is something new for the industry, explaining that: “To our knowledge there is currently no main competitor offering the same comprehensive test menu.

“With the new metabolite tests for our Cedex Bio systems we currently offer the most comprehensive testing portfolio for cell fermentation analytics​.”

Roche will use the new reagents for its in-house biomanufacturing projects and will provide them to its customers in the biomanufacturing sector which – according to Dr Schmitt – include many of the leading BioPharmas and drugmakers.

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