New Guide for Determination of Fermentation-derived Protein
1. Scope
A standard method for analysis of fermentation-derived proteins will enable the detection and quantification of proteins in the downstream products of industrial biotechnology. These products include specialty and technical enzymes, fuels, chemicals, foodstuffs, beverages and other materials derived from industrial fermentation processes. Proteins of interest include those produced by specific industrial microbial expression hosts, proteins derived from upstream feedstocks such as animal and plant-derived fermentation media, contaminating microorganisms present in fermentation and downstream processes and proteins used as processing aids during fermentation, recovery and formulation unit operations. The method will describe the use of one or more analytical techniques, for example total protein determination, HPLC, immunoassays, enzyme assays and mass spectrometry. A flow chart will be developed to help determine what specific techniques should be applied, depending on the nature of the product to be tested and specific customer or regulatory requirements. The method will enable testing of a variety of sample types and include recommendations for suitable internal standards and how to deal with sample matrix effects. This method will enable producers to demonstrate the identity and amount of both desired and contaminant proteins in the products of industrial biotechnology to both customers and regulatory bodies.
Keywords
biotechnology; protein; fermentation; HPLC; total protein; enzyme assay
Rationale
This method will enable producers to demonstrate the identity and amount of both desired and contaminant proteins in the products of industrial biotechnology to both customers and regulatory bodies.
