Publication Details (including relevant citation information):
Dawn E. Smit, Carl Lentz, & Dene H. Taylor, Ice-Binding Protein Conference, Queen’s University, Kingston, Ont., August 2011
Most biopharmaceuticals such as vaccines are thermally sensitive.(4) Global vaccination programs against infectious diseases and toxins are estimated to save approximately 3 million lives yearly. Tragically, however, another 3 million individuals (primarily children) die of vaccine-preventable diseases. A significant portion of this problem results from the thermal instability of many of the currently used vaccines.(5) Since the biopharmaceutical distribution system "Cold Chain" often has breaks the only way to identify temperature abuse is through accurate reliable monitoring. This presentation will discuss the development, commercialization and desired technical improvements of a freeze indicator that uses ice nucleating protein as a key component. Ice nucleants like SnoMax® (freeze-dried Pseudomonas syringae) address super-cooling, and stabilizers reduce degradation and prevent microbe growth. But the nucleant still has variability and degrades over time, depending upon the dispersion chemistry and type & amount of stabilizer. Sensitivity to pH and response to stabilizer content of a freeze-indicator formulation are presented to stimulate discussion on some of the challenges this technology faces.