EPM catches up with Kevin Lawler, vice president of worldwide sales at Pelican BioThermal to discuss all things cold chain
Kevin Lawler
Q: How is the temperature-controlled packaging industry responding to the rising regulatory requirements within the pharmaceutical cold chain?
A: Increasing regulatory requirements and compliance within cold chain to ensure the safe transportation of pharmaceuticals and biologics means temperature-controlled packaging (TCP) manufacturers must be at the forefront of industry innovation.
With the significant rise of biologics and biosimilars, the need for temperature control is ever increasing, where any minor temperature excursion within the cold chain can have costly consequences for patients and pharmaceutical companies alike.
The fact over half of approved new pharmaceuticals are going to be biologics or biosimilars, is proving another driver in the rising demand for tighter temperature control requirements making innovation in - (TCP) - increasingly vital.
It’s in direct response to the pharmaceutical industry’s rising requirement to protect more of their shipments with strict temperature controlled ranges. The primary driver of this is due to a growing trend in new pharmaceuticals being based on biological compounds which require strict temperature controls, rather than chemical, which have less efficacy than biologics, but less strict temperature requirements.
Q: What are the main cold chain challenges to consider when transporting pharmaceuticals?
A: More complex distribution lanes, with emerging markets, geographies and increasing regulatory compliance conditions are some of the challenges when transporting temperature sensitive biologics/biosimilars.
The increased need for last-mile pharmaceutical transportation is a growing trend, as well as requiring stringent compliance throughout the cold chain process to ensure the protection of high-value, temperature sensitive, pharma payload end-to-end on its journey from the manufacturing facility to the patient’s hands.
Industry innovations are also required in response to the rise globally of regulatory activity by agencies and organisations producing specific-in-country guidelines and regulations the pharmaceutical companies are required to support and be prepared for.
The TCP industry is governed by stringent GMP (Good Manufacturing Practice) standards, as well as GDP (Good Distribution Practices).
Standards bodies, including the International Organization for Standardization (ISO), ensure packaging is fit for purpose, cost-effective, all while being safe and reliable, understandably, a pharmaceutical critical prerequisite.
Q: How are innovations in TCP helping mitigate cold chain risks?
A: A rise in the acceptance of innovative materials such as advanced phase change materials (PCM) and vacuum insulated panels (VIPs) for insulation purposes helps manufacturers and service organisations maintain temperature throughout the cold chain. These innovations avoid temperature excursions, which could render the pharmaceuticals unstable, causing them to lose efficacy.
Emerging TCP featuring ‘hibernation’ capabilities combat customs delays. These new generation packaging systems can be placed in a refrigerated area, suspending or stopping the loss of energy retained by the shipper.
Within pharmaceutical distribution and biological sample transportation, there is a move towards more advanced VIPs and PCMs instead of utilising the traditional, water-based systems.
The advent of innovative temperature controlled packaging allows TCP companies to improve packaging performance and technical tools that aid with performance modeling. These efforts are helping revolutionise the TCP industry, allowing it to respond more quickly to changing demands from their customers.
These modeling techniques included software, which allows companies to develop a temperature profile easily, which they might want to test against a specific shipping lane and packaging solution.
Newer technologies allow pharma companies to utilise shipping systems with a reduced number of components and coolants incorporated in the packaging process. This simplification is another contributor that provides elimination of pack-out errors, which are the cause of many temperature excursions.
Temperature indicators on PCM panels, which display when they are ready for use and packing, are also new to the sector. These further aid the protection process in cold chain by avoiding errors, which ultimately offers more efficient payload protection and reliable shipping solutions.
Q: How can cold chain distribution costs be reduced?
A: Currently the industry is moving towards newer technologies, looking at tools to assist in the management of more modern PCMs, which are more technologically advanced over managing traditional water based systems.
There has been a notable move away from incorporating older technologies, such as water-based ones, which required seasonal packaging components, sometimes covering all four seasons, which in turn required seasonal instructions, which drives the need for further training and additional warehouse personnel.
Performance improvements and cost savings can be made and passed on through the supply chain process by reducing processes required and subsequent training.
Convincing pharmaceutical firms of the importance of having the fit for purpose cold chain shipping systems, as part of their overall operations and budget considerations, is an ongoing challenge.
It comes down to helping pharmaceutical manufacturers better understand the true cost of impact of moving to newer technologies and what impact that can have for their operations. Ultimately ensuring stability in the supply chain is critical within the pharmaceuticals industry where patient safety and efficacy are an absolute priority.
Q: What measures can be taken to reduce environmental impact within the industry?
A: Future trends will see the increase in the use of reusable packaging.
Although single use packaging still serves a purpose, particularly when it comes to more difficult to control or challenging lanes, when the retrievable infrastructure is in place, reusable, which is on the rise, can prove a more cost effective option per trip.
Reusable technology is becoming more and more accepted because it can really drive down costs per use. The packaging industry is working hard to try and change preconceived perceptions about reuse and its reliability.
Future developments will involve industry standards, which demonstrate ways to guarantee reusable containers are fully qualified, remaining fit for purpose after multiple uses.