Patent ID: 8190374

Claim:
A method for monitoring a therapeutic protein drug for immunological risk, said method comprising; providing a time-temperature integrator indicator device to integrate time and temperature, an indicator output device, and a time-temperature indication parameter setting device; said indicator having at least one time-temperature indication parameter selected by the steps of: monitoring chemical and structural changes in the therapeutic protein as a function of time and storage temperature; determining which time and temperature conditions cause a certain percentage of said protein to undergo structural or chemical alterations; said percentage being set at a predetermined immunological risk threshold wherein amounts above said threshold have an unacceptable risk of provoking an immunological reaction; in which it is unwanted that said therapeutic protein drug provoke an immunological reaction in the absence of said structural or chemical alterations, and in which said therapeutic protein drug is not a vaccine; said immunological risk threshold being set at or below ten percent of the total quantity of said therapeutic protein; setting said time-temperature indication parameter of said indicator with said immunological risk time-temperature data; associating said immunological risk set indicator with said drug throughout the cold chain or distribution chain between the manufacturer and the ultimate end user so as to detect disruptions in said cold chain or distribution chain during the drug's storage life; and monitoring the immunological risk status of said therapeutic drug by observing the indicator output of said time-temperature integrator.