Growing Importance of Cold Chain in Life Sciences

Growing Importance of Cold Chain in Life Sciences
COVID-19 immediately shed light on the importance of cold chain logistics, but the sector has been, and continues to be, an increasingly important part of the life sciences industry.

COVID-19 immediately shed light on the importance of cold chain logistics, but the sector has been, and continues to be, an increasingly important part of the life sciences industry. The life sciences industry continues to shift towards researching and producing regenerative medicines, biopharmaceuticals, and other fragile products (henceforth named biological drug products). These biological drug products require carefully controlled environments in order to protect product integrity.

Biological drug products are sensitive to the environments in which they are manufactured and distributed. Small variances in temperature can cause quality issues and product failure. In addition, these medicines are often irreplaceable, more expensive than pills/tablets, and defections/usability are difficult to determine post distribution. The only way to ensure viability of the medicines after distribution is through both a well maintained cold chain and a constant flow of information regarding shipment conditions.

Cold chain logistics is the technological process of transporting temperature sensitive products through the supply chain. Perishable products are often packed, handled, shipped, and stored in temperature controlled environments to ensure product viability. Oftentimes it is referred to as the “cold chain.” Any time a product is exposed to temperatures exceeding a predetermined threshold, the cold chain has been broken, and the product is at risk of becoming defective.

Shipping perishable products in temperature controlled environments has been around since at least the 1700s, when ice was used in the transport of fish to keep it from spoiling. Recently, with the advent of modern technology (and modern products that require stringent control), cold chain logistics have become technologically advanced - improved refrigeration, real time monitoring, increased data connectivity and flow, etc. In 2020, the global cold chain logistics sector was worth $248 billion and is expected to grow to $410 billion by 2028. Sharing data and establishing a chain of custody throughout the cold chain is crucial to upholding the quality of biologics. Many organizations, including the FDA, have built standards not just around the physical transport of biologics, but also the technology, systems, and information utilized. And while many technologies have changed to aid in the control of temperature and the gathering/sharing of data, one piece of the puzzle that remains is the product label.

The use of labels to identify products and status is a pillar of Good Manufacturing Practices (GMP). Labels can be applied to pallets, cases, and unit level product packaging to convey information about the product contained in the packaging. With the growth in biologics, and subsequently the growth in cold chain logistics, utilizing a label that can withstand the rigors of temperature controlled environments is a requirement.

GMP Labeling offers stock and custom labels that can withstand the coldest temperatures utilized in cryogenic products, including exposure to liquid nitrogen. The materials we use ensure that the label maintains integrity and adheres to the packaging throughout cold distribution. Because, at the end of the day, no matter how well maintained your distribution chain is and how calibrated your temperature monitoring devices are - a biologic product can not be used if it can’t be identified with a label.

Check out our stock cryogenic labels here or reach out to GMP Labeling via email (sales@gmplabeling.com) or phone (916-771-4000) to learn more about how we can help you and your organization maintain GMP compliance in your cold distribution.