For biopharmaceutical manufacturers, the market trends are favorable. Rising demand for targeted therapies and the globalization of specialty pharmaceutical commercialization are creating a host of growth opportunities for manufacturers. As a result, there is an unprecedented rise in the quantities of commercial and clinical drugs that are being shipped to patients across the globe. However, this also means that the stakes and costs for high-value cold chain products in global clinical trials have undergone a dramatic increase, due which the industry now operates in an environment where there is increased focus to minimize the loss on products or samples. This necessitates global manufacturers in the biopharmaceutical sector to keep abreast of the advances in biopharmaceutical cold chain packaging technology and processes that maintain the quality standards and ensure the safety of cold chain products. In this article, pharma industry experts lay down some macro-trends and key takeaways in biopharmaceutical cold chain packaging that manufacturers must consider as they work to identify innovations and drive new growth globally.
Meeting unique temperature needs
The rising hype around targeted therapies, biologics, and personalized medicines demand better temperature control measures in the biopharmaceutical supply chain. The wider range of new temperature requirements for these products requires manufacturers to focus on more than just cold shipping, it requires new biopharmaceutical cold chain packaging solutions. It becomes highly challenging to maintain product temperatures in a laboratory or storage setting. The difficulty increases exponentially in case the products must travel at a consistent temperature across thousands of miles over several days or weeks altogether. In such cases, product integrity can only be ensured through the right biopharma cold chain packaging solutions. Fortunately for biopharmaceutical manufacturers, there has been a significant expansion in the packaging and monitoring technologies for the biopharma cold chain. Semi-active packaging, including expanded polystyrene (EPS) and expanded polyurethane (EPU) systems, remain as one of the most common and economical biopharmaceutical cold chain packaging choices for local or short-distance transportation. But this type of packaging solutions are unable to regulate their own internal temperatures and require a change in packaging configuration seasonally even if the route doesn’t change. Passive cold chain packaging solutions, on the other hand, are more focused on offering longer temperature control durations with lighter materials. These solutions are proven to maintain temperature control even through longer distances. GPS technologies and tracking can be used to monitor and gain a real-time view of shipment status throughout the products’ journey.
Expanding global clinical trials
The number of registered clinical trials across the globe has cross 1 million. The need for efficient global clinical trials are increasing with the rising regulatory mandate for tests to be conducted within the country where the manufacturers seek launch and market new drugs and targeted therapies. With the expansion of the global clinical trials market, there are significant hurdles that manufacturers must overcome in order to ensure that products arrive at the right place, at the right temperature, and within the expected time frame. Navigating geo-political roadblocks to ensure higher performance of the clinical and commercial supply chain is crucial for both manufacturers and cold chain packaging partners. To avoid any hindrances to clinical trials of drug shipments in emerging countries for time and temperature-sensitive medications, manufacturers should consider working with specialty logistics experts in these countries.