There is, to put it mildly, a wide range of practices when it comes to monitoring and tracing the shipments of temperature-sensitive materials and products in life sciences. The baseline, if you will, is: nothing at all. A considerable number of shipments in the US and globally (less so for countries, or companies, adhering to strict GDP standards) are set up based on two assumptions:
When comparing models, many firms struggle to determine which packages they should invest in to transport their medicines; due to the lack of standardization in the qualification testing conducted by manufacturers.
The existing guidance on qualification testing is helpful, but the number of different thermal profiles and testing procedures used in the market (regarding product loads, preconditioning requirements, etc.), can create confusion when trying to directly compare containers.
Organizations change for a range of reasons: to close performance gaps, seize new opportunities, to accommodate for a new merger or perhaps abandon certain projects in favor of more successful ones.
Pharma is one of the most conservative industries –namely due to the fact that its products are high risk – very influential to the health, well-being and in some cases the survival of their consumers. Regulations must be met to ensure that medicine quality and patient safety is
The Mayo clinic defines personalized medicine as “individualized, precision or personalized medicine provides a genomic blueprint to determine each person's unique disease susceptibility, define preventive measures and enable targeted therapies to promote wellness. (1)”. In short, the tailoring of medical treatment to the individual characteristics of each patient. As a result, the rise of personalized medicine is expected to (2):
Numerous factors such as the surge of retiring baby boomers, increased demand for workers with complex skill sets, and changing labor demands have resulted in an unprecedented, cross-industry talent acquisition crisis. Unless we as a society completely rethink the way we work, this shortage of skilled talent is only expected to intensify over the next few decades. Furthermore, this war for talent could disproportionately impact the life sciences supply chain sector. Currently, the demand to supply ratio of jobs to qualified individuals in the
When the EU GDP standards were established in 2013 expanding temperature-control compliance requirements to CRT products, the first reaction of many companies was to apply the same technology as refrigerated containers—insulated boxes with gel packs. However, not only is it more difficult to keep a product at room temperature (because of the mass of PCM material necessary) than a refrigerated product, (whose PCM can pack more cooling into a given mass), it can also bbe significantly more expensive. Considering that, at least according to some estimates , 90–93% of drugs in the market are CRT (10X the size of the cold chain market), if companies were to
We don’t have to tell you that effective temperature management is critical for ensuring the safety and effectiveness of all types of drugs, even those that may not classify as “cold chain” products such “ambient” or “room temperature” medicines.
Not too long ago, “ambient,” “room temperature” and even “controlled room temperature” (CRT) were considered synonymous and, as they were considered more or less resilient again temperature excursions, were provided little to no thermal protection across the supply chain. However, this is beginning to change. Increased regulatory focus, an improved understanding of how inappropriate storage
The pharma industry stands at a defining moment. According to the 9th edition of Pharmaceutical Commerce’s Biopharma Cold Chain Sourcebook, the sales of global cold chain and biopharma drugs are set to grow by 31% (318 billion- 416 billion) from 2018-2022, outpacing the non cold chain growth at 17% (870 billion- 1014 billion) , and the overall volume of temperature-controlled pharma products is growing at twice the rate of the pharma industry as a whole. This reflects an overall growth trend of 53% since 2016. Likewise, logistics spending in the cold chain space is expected to grow from $15 billion (10.6 in transportation and 4.4 in tertiary packaging and instrumentation) in 2018 to over $18.6 billion in 2022.