In drug development and translational medicine, consistency matters

     

Consistency is among the most important concepts in drug development and translational medicine. Yet, the tests that identify whether a specific substance is present in a sample have so much variability, even among batches, that comparing results over time is difficult, if not impossible.

Measuring devices, whether they measure the presence of biomarkers in the lab or the temperature of medications during shipment, must deliver consistent, accurate, results. This is especially true for the biologics and vaccines, where inconsistency can ruin shipments. For example, flu vaccines should be maintained between 2° and 8°C and never frozen, but manufacturers say they freezes at 1°C and must be discarded at 0°C. If the temperature monitor measures temperature inconsistently, ineffective vaccines could be used.

It is, unfortunately, a significant problem. Studies by PATH, an international healthcare organization, found that between 75% and 100% of vaccine shipments were exposed to freezing during distribution and between 14% and 35% during transportation. Degrees matter; and an improperly calibrated cooling system could render vaccines worthless.

That’s why an accurate, consistent temperature monitoring program is vital. Simple indicators can provide assurance that pharmaceuticals were handled properly throughout distribution and storage. Before choosing your temperature monitoring solution, consider these questions:

  • Is the variability of the monitoring device the same at -30°C as it is at 75°C?
  • Are device accurate and variability consistent batch-to-batch?
  • Is your monitoring solution tested on equipment calibrated to meet National Institute of Standards and Technology (NIST) standards?
  • Does your solution meet ISO 9001:2008 standards?
  • Is it in compliance with good manufacturing practices?
  • Does it support 21 CFR Part 210 and 211?
  • Has it earned the European Union CE mark?

You should be able to answer “yes” each time, ensuring that the solution you choose to monitor sensitive pharmaceuticals can do the job.