Pharmaceutical logistics service providers in Asia and globally will need to respond to a range of emerging new challenges – requiring further significant investment – over the next few years.

One of the hardest to deal with could be the development of personalized medicines and treatments. “When you are dealing with an individual drug made for an individual patient you clearly cannot afford to get anything wrong in terms of handling and distribution,” pointed out Tony Wright, CEO of Exelsius, a UK-based consultancy specializing in good distribution practice for pharmaceuticals worldwide.

Mark Whitehead, chief executive of Hong Kong air cargo terminal operator Hactl, highlighted a similar issue. “There is growing talk of straight-to-patient medication and although there is little practical evidence of this so far, it seems inevitable in this online-driven, overnight despatch world that it will be progressively adopted on a large scale.”

However, he added, “it is too soon to say how far this trend will be adopted and whether it will generally utilize traditional air cargo channels or find its own new routes and technologies.”

The emergence of those challenges and their potential impact on logistics requirements was confirmed by Leonora Lim, vice president, life sciences and healthcare, Asia Pacific, for DHL Customer Solutions & Innovations.

“The life sciences and healthcare market is becoming more patient-centric, with customized treatments and medicines for patients. Patient access to healthcare is being extended beyond hospitals to their homes, resulting in a rise in home deliveries and home-based care. The market is also seeing easier access to medicines, for example, through e-commerce, online platforms, etc,” she said.

A third challenge to logistics providers which is already apparent but is expected to become ever more widespread is how to safely handle highly temperature-sensitive biopharmaceuticals (products derived from biological sources).

The rapid growth of that sector was highlighted by Cryoport, a US-based provider of cold chain logistics solutions for temperature-sensitive life science commodities, in its 2017 first quarter results statement.

“The quarter’s results were driven by extraordinary growth in our core business of providing cold chain logistics solutions to biopharma clients, which saw revenue grow 100% year-over-year,” said Jerrell Shelton, Cryoport’s CEO.

That business development, he said, was mainly being fuelled by growth in the regenerative medicine market, adding that Cryoport was “well-capitalized to scale our solutions as more regenerative medicines approach commercialization and require significantly more logistics support and services.”

Mark Sawicki, the company’s chief commercial officer, told Asia Cargo News those plans included “initiating a review of our current service needs in Asia and looking at expansion within Europe.” Currently, he said, Cryoport has a support depot in Singapore to support its operations in Asia and one in Rotterdam, Netherlands, for Europe.

A fourth developing challenge was outlined by a spokesperson for global forwarder Kuehne + Nagel, which claims to have been the first logistics provider to have its entire global air network certified to the International Air Transport Association’s CEIV Pharma (Center of Excellence for Independent Validators in Pharmaceutical Logistics) standard.

“Serialization (the application of a unique serial number for each saleable unit to provide full visibility/authentication through the supply chain) will be a distinguishing factor in serving the pharma and healthcare industry moving forward,” said the spokesperson.

“All batches produced will require visibility down to secondary packaging/patient pack level. To enable tracking and tracing to the SKU (stock keeping unit) level service, providers will require a robust IT platform capable of providing the information required. The IT platform must be validated/certified to pharma software standards.”

Meanwhile, logistics providers servicing the pharma sector are continuing to further strengthen their credentials and product-handling capabilities for existing traffic.

In the case of the former, many have over the last two or three years secured a GDP (good distribution practice) compliance standard and/or other official recognition, notably the IATA CEIV Pharma certification.

Recent examples in Asia of the IATA certification include DHL, which certified its air freight stations in Shanghai, Tokyo Narita and Singapore, and Hactl, which had previously also secured accreditation under the WHO (World Health Organization) GDP standard. Other standards are also being secured – DHL, for example, has over 150 warehouses worldwide which are GMP (good manufacturing practice) certified for the handling of pharma products and provision of services such as secondary repackaging.

Logistics providers have also continued to step up their investment in information technology capable of providing full consignment visibility throughout the pharma supply chain and in additional specialized physical facilities to improve the handling of such products.

Further investment will be needed in both those sectors, suggested the Exelsius consultancy’s Wright. “Investment in IT and tracking to provide a level of visibility which is consistent with good high-quality standards will be driven forward by the development of e-commerce,” he said.

“However, there are also still many places around the world where the physical facilities are not yet up to the required standards and where further investment is needed. So, there remains work to be done on the basics.”

In that context, Hactl’s Whitehead stressed the importance of all players in the pharma supply chain putting in the necessary investment to ensure product delivery reliability and safety. “The industry is waking up to the realization that a pharma supply chain is only as strong as its weakest link,” he stated.

“In encouraging players in the industry to make the necessary investments, it’s important that we have a critical mass of companies who are aware of demands from shippers and are all moving in the same direction.”

The continuing investment to ensure all links in the pharma supply chain are secure was highlighted by Emirates SkyCargo’s inauguration of a new 4,000-square-metre pharma-dedicated facility at Dubai International Airport late last year. The carrier already had such facilities at its Dubai World Central airport freighter hub.

“We also secured EU GDP certification for pharma transport facilities and operations at our Dubai hub,” said Henrik Ambak, Emirates senior vice president, cargo operations worldwide.

Now, he continued, the carrier was developing origin-to-destination Pharma GDP lanes “so the cargo will move under a certified service from handover by the shipper to delivery to the consignee.”

Similar plans are being developed by Swiss WorldCargo whose Zurich home hub ground-handling partner Cargologic was among the first in Europe to be recognized as fully GDP-compliant by Swiss drug registration institution Swissmedic and also subsequently obtained IATA CEIV Pharma certification.

“Across our network we aim to establish ‘quality corridors,’ certified pharmaceutical lanes that consistently meet the highest quality standards and product integrity. The first such corridor was launched last year between Zurich and Singapore,” said Alain Guerin, Swiss WorldCargo’s director, head of products, services & technology management.

“We are now working on replicating this model to have many more pharma lanes certified. We are talking to our handling agent partners to identify and prioritize the key such lanes for that certification.” Guerin added that those plans were now “very advanced and we will therefore be able to offer a solid certified network in the near future.”

By Phil Hastings

Correspondent | London