Cold Chain Labeling

Written by: Citation Expert
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The study and engineering of healthcare remedies began long before the mid 1800’s, but it’s around that time organic compounds like morphine became available commercially as a source of pain relief.  The first rudimentary clinical trials occurred during the 1500’s, but it wasn’t until 1943 in the UK when the first double blind, regulated clinical trial took place.  Since then, discoveries and breakthroughs in drug remedies have been occurring more frequently, and with greater complexity when it comes to molecular structure.

Take an oral-route OTC pain relief medication, for example. The molecular weight of this medicine is relatively low, and size-wise the molecule is relatively small. These characteristics make the medicine relatively stable and better able to tolerate extremes in temperature. If you leave your aspirin or ibuprofen in a hot car, it won’t lose its effectiveness.  On the other hand, some medicines have relatively larger and heavier molecular structures, making them less stable.  Oncology drugs in particular are being developed with substantially larger molecular structure, and these medications require specialized development, storage and supply chain logistics to maintain the efficacy of the drug.  Medications such as these are often stored in cryogenic freezers and shipped over dry ice.  These conditions necessitate unique and innovative solutions from a labeling standpoint. Cold chain labeling is growing and emerging as one of those solutions.

Cold Chain Labeling

Cold chain labeling is a packaging and labeling process designed to work within the volatile environments present in the development and supply-chain for less stable drug formulas. These conditions present unique challenges, particularly on the label application side.  In many cases, vials of medication are pulled from cryogenic freezers set to -80⁰C, and then labeled over dry ice.  Adhesive technology has not yet caught up with the demands of this type of labeling environment. Even the most aggressive adhesives have only proven suitable down to -20⁰C.  Successful development and implementation of cold chain labeling will be vitally important as more of these unstable formulas are developed.

Consider a clinical trial scenario:  Patient-specific dosing often requires data and/or organic material from the patient prior to packaging doses. This in turn requires labeling to be performed after filling of the dosing container. Ensuring effective label adherence to clinical trial packaging is paramount to the success of the trial, and to the study of the drug’s performance overall.  And regarding what is ultimately the most important measure, label adherence could literally mean the difference between life and death. If a label were to fail completely during a trial, a sick patient who is susceptible to positive results in a trial drug could die as a result of receiving an incorrect dosage.

The biggest barrier to R&D for new cold chain labeling technology is the segment’s relatively small footprint compared to other pressure sensitive label applications.  Consider the expansive scope of labeling all the products you see on a daily basis, and then consider the number of times you’ve come in contact with a material being pulled from a cryogenic freezer for use.  Simple lack of scale is impeding innovation and development of the adhesive technology required.

This is why Citation is currently working with our supplier partners to test a variety of new and existing materials in various cryogenic environments.  We are gathering and analyzing data on label components that exceed performance expectations, and assessing opportunities for use in new cold chain labeling products.  These efforts alone won’t fill the gap in adhesive technology, meaning label design will remain the most important factor to labeling and packaging strategy in these volatile environments.  Citation’s expert label designers are available to customize solutions for your Investigational Medicinal Product (IMP) in any situation. Reach out to our team to find out more information on cold chain labeling!

https://www.azbio.org/small-molecules-large-biologics-and-the-biosimilar-debate