Recombinant Proteins for Industrial versus Pharmaceutical Purposes: A Review of Process and Pricing | White Paper
Posted 31st January 2020 | Last updated 3rd August 2020
Prof. Florian Wurm (ExcellGene CSO) and John Puetz from the Department of Pediatrics, Division of Hematology/Oncology at Saint Louis University School of Medicine have collaborated on the White Paper: Recombinant Proteins for Industrial versus Pharmaceutical Purposes: A Review of Process and Pricing.
Florian M. Wurm, Prof. Emeri.
Note from the author, 3rd August 2020 | This paper has exceeded 6,000 downloads in less than a year since publication! Prices for recombinant proteins for therapy and for industrial (non-medical) applications differ over several logs (100-10,000 fold). Our review explains the reasons for this. It becomes evident that the cost of a recombinant protein depends on the context for its use. As an example, an industrial protein, such as for laundry detergents (proteases), will not enter the human body and thus has much lower safety criteria to fulfill than a bloodstream injected antibody. This means that prior to selling a protein, dramatically different amounts of fundamental and applied scientific efforts have to be done and documented before a new protein product can be sold.
Recombinant proteins have been produced for over 30 years. Applications range from enzymes used in laundry detergents to antigen-detecting antibodies in cancer therapy. Despite similarities in manufacturing, drastic differences in retail pricing between recombinant proteins used for industrial (non-medical) versus pharmaceutical purposes exist. Industrial proteins often have a retail price in the tens of dollars per kilogram while recombinant proteins for medical use may cost billions of dollars per kilogram. This manuscript will briefly review manufacturing techniques and contrast the differences between industrial versus pharmaceutical production. Maximizing manufacturing technologies to reduce cost-of-goods (CoG) is desirable. However, the major reason for the very high pricing of pharma protein products does not reflect CoG, but the financial obligations of clinical trials, research and development, patent constraints, marketing, and return on investment.