Process Development & Manufacturing

Quantitation of the protein drug substance

Up-stream and down-stream development of the process for manufacturing of recombinant and natural protein pharmaceutical require that the protein drug substance can be quantified in the various process steps. The quantification method is needed to optimize the fermentation yields as well as the protein purification efficiency during process development.
Later the quantification method is used for in-process control and batch documentation.

Early development of a LC-MS/MS quantification method specific for the protein will allow it to be used throughout process development and manufacturing process documentation.