Pharma logistics smart deliveries

The rapidly evolving pharmaceutical industry is making pharma logistics to do things differently and they are getting smarter with advanced track and trace technologies. Reji John…

Transportation of pharmaceutical products by air has been going through rapid change and innovation under the constantly evolving regulatory framework which demands the protection of pharma product integrity right through its complex supply chain network.

Similarly changes in the pharmaceutical industry are triggering changes in the distribution of drugs. More drug companies are focusing on specialty drugs including hormones and cancer therapies. Those often require more stringent temperature controls during the transportation process. As a result logistics services providers are investing more heavily in temperature-controlled warehouses and vehicles, as well as packing facilities that meet life sciences industry standards set by regulators around the world.
Some of the biggest global logistics companies are preparing for a boom in spending on specialty drugs that require temperature-controlled shipping by investing in so-called cold-chain infrastructure. Recently UPS announced that it is building a health care distribution center in the Netherlands, just a month after opening an air freight facility at the Amsterdam Airport Schiphol dedicated to health care shipments.

In fact a recent white paper by Deutsche Post DHL claimed that pharmaceutical manufacturers face an “exponential growth in the need for temperature assured distribution and handling of materials, from active ingredients to finished products.” This is coming from the fact that pharmaceutical companies are moving away from so-called “small molecule,” chemical-based drugs, which include most over-the-counter pill-based medications to more structurally-complex biotechnology drugs, including hormones and cancer drugs, which in general require strict temperature controls when transported.

“The pipeline of drugs waiting for approval over the last few years has been biologically-based drugs with large molecular structures. These require temperature control. What we’re seeing is an acceleration of that right now,” said Angelos Orfanos, president, life sciences and health care, DHL.

In the last two years, DHL has invested heavily in staff, warehouses and facilities equipped to handle temperature-sensitive shipments—many of which require a package to be kept at between two and eight degrees Celsius for the duration of a shipment—and which must meet Food and Drug Administration and European Medicines Agency standards for quality control.

It is not just the biggest logistics companies that are investing in building up infrastructure for the high value pharma products which require temperature controlled transport solutions. Airport and airlines have been upgrading facilities and launching niche products and services to tap into the huge potential for business that exists in this sector.
Last month American Airlines Cargo officially opened the ExpediteTC cold storage pharmaceutical facility in Philadelphia, Pennsylvania. Strategically placed in the northeast pharmaceutical corridor, this high-tech facility and its specially trained employees are key elements in the effective handling of the sensitive, valuable and potentially life-saving products shipped through the international cold chain. This facility is a continuation of American’s investment in the infrastructure to support the ExpediteTC time- and temperature-sensitive programme.

“With our quickly growing network at American, we see a great importance in investing in our infrastructure and people,” said Jim Butler, president, American Airlines Cargo. “We will continue to evolve our products and services as needed to ensure these sensitive shipments remain just as safe and potent for the end user as designed by the manufacturer.”

The carrier is also investing in global training programmes designed to provide employees the knowledge and skills to properly handle these delicate shipments.

Etihad Cargo, the freight division of United Arab Emirates carrier Etihad Airways, earlier this year unveiled TempCheck, its new cargo solution created to ensure the integrity of all temperature-sensitive pharmaceutical and healthcare products as they are transported around the world.

All temperature-sensitive pharmaceutical products, including blood plasma, tablets, medicines and anaesthetics, must be kept within different temperature ranges in compliance with industry and regulatory guidelines, to ensure the products retain their integrity and are protected from degradation due to exposure to heat and cold during the transportation process.

Supervised by trained and experienced service teams and ground handling staff, TempCheck incorporates the latest equipment, processes and operating procedures that keep all pharmaceutical products within a temperature controlled environment at every stage of the journey, from the cool room facility to the ramp, and from the aircraft to the customer. David Kerr, Etihad Airways Vice President Cargo, said:
“Over the last two years we have seen tremendous growth in the amount of pharmaceutical products we have successfully transported over our hub in Abu Dhabi as we continue to expand our passenger and cargo networks,” said David Kerr, vice president, Etihad Cargo
To meet this increasing demand, Etihad Cargo has also upgraded its temperature controlled storage facilities in Abu Dhabi, and has refurbished its existing cool rooms to meet pharmaceutical-safe specifications. “We have been working closely with our pharmaceutical customers in developing this specialised solution, which has been designed to ensure that their temperature-sensitive pharmaceutical products are protected at every stage of the journey, and reach their final destination in perfect condition,” Kerr added.

For Cal Cargo, with 40 years of experience in handling temperature controlled freight, 35 percent of the business comes from temperature controlled cargo, in which pharma holds a significant position. Cal Cargo has extensive experience providing a temperature controlled corridor from point of origin to point of destination, including pickup from producer through ground transportation, airport handling, storage and delivery. Talking about growth rate seen in the pharma segment Navot Hirschhorn, temperature controlled & special products manager for Cal Cargo said: “In 2013-2014 we saw a 30 percent growth in the use of active containers for pharma products. And in 2015 we see similar growth, which we expect will increase even more in 2016.”

Cal Cargo recently announced its participation in IATA’s Center of Excellence for Independent Validators (CEIV) pharma programme. “Once completed (July 2015), we will be the first group to have a certified pharmaceutical logistics programme throughout our logistics hub at Liege Airport,” said Hirschhorn.

In fact, Brussels Airport is ready to roll out the second wave of pharma certification. The pharma experts of nine BRUcargo based companies, including some of the big forwarders and several trucking companies are attending the dedicated training cycle of the CEIV pharma programme. Additionally Brussels Airport has brought in FAGG - the Belgian regulator - and pharma shippers to join the programme.

“This (CEIV pharma programme) will enhance interactive discussions and the exchange of ideas and best practices to improve the handling of temperature controlled shipments at BRU,” said Steven Polmans, Head of Cargo, Brussels Airport Company. At the end of the programme and completion of assessment all stakeholders will be brought to the same high quality level, contributing to reliable and transparent handling of pharma shipments.

Recognizing the importance of cargo safety and security, UK-based forwarder SDV was one of the first to participate in the 2014 pharmaceutical certification programme at Brussels Airport. Subsequently, SDV has decided to pursue certification for an additional 16 major air hubs in Europe, Asia, North America and South Africa, via IATA’s CEIV pharma certification.
The first two of these certifications are to take place at SDV’s stations at Singapore Changi International and at Roissy Charles de Gaulle in Paris, said Brice Bellin, SDV’s healthcare regional director for Western and Central Europe. Both are scheduled to be completed by September or October of this year, he said.

Based on positive feedback and benefits from the “BRUcargo” community approach at Brussels Airport, SDV committed itself to certifying the additional hubs”, Bellin said. The rest of the SDV healthcare stations are expected to by CEIV-certified by the spring or summer of 2016. “The investment, in terms of time, money, resources and organisation, is heavy,” he added. “To be done seriously, and as a pilot, it cannot be done in a few weeks.”

“Under the CEIV-Pharma programme, SDV is currently setting up a training schedule that will last for eight days and will involve four people from each participating station”, Bellin said. The certification will be carried out by an independent validator, who has been trained by IATA to perform the necessary assessments and audits. “It is also an opportunity to demonstrate the industry that we do not handle pharma business the way we did a few years ago,” Bellin added.

The CEIV certification aims to be the standard-bearer in the end-to-end safe handling of pharmaceutical goods worldwide. SDV – which has been a member of IATA’s Time and Temperature Task Force for more than three years, has been working on this project with IATA for the last two years – has a network of specialists located near main regions for pharmaceutical production, particularly generic products and biotechnologies. The company also strictly enforces security and safety rules for all cargo, follows rigorous cold chain management protocols and manages the flow of relief aid from several origins to emerging economies.

Finnair Cargo recently passed IATA’s CEIV certification programme. The certificate was presented to Finnair Cargo in conjunction of the laying of the cornerstone of Finnair’s new cargo terminal, the COOL Nordic Cargo (CNC) hub. The new state-of-the-art terminal will feature separate temperature controlled areas for the handling of pharmaceuticals as well as other perishables. “We are committed to be at the forefront in the fast growing pharma transport segment and provide excellent service to our customers. Therefore, we are honored to be the first carrier in the world to complete the IATA pharmaceutical certification process,” said Juha Järvinen, Finnair’s Chief Commercial Officer.

For many pharmaceuticals, a two-degree Celsius temperature variation is all that’s needed to spoil the entire lot.
Maintaining just the right temperature is a challenge for anyone who ships or stores pharmaceuticals, but it’s an even larger obstacle for companies shipping from the warmer climates where many drugs are made today.

“When you’re moving product out of locations such as Hyderabad and Bangalore, a long X-ray screening process at the airport can create complications,” said Richard Smith, managing director of life sciences, specialty services, global trade services at FedEx.

When temperatures slip, companies lose an average of $150,000 on a small package shipment. For large freight shipments, damages can run into the millions. To prevent these losses, shippers and their service providers have developed some sophisticated techniques for maintaining the cold chain.

Many companies also use sensor-based systems to document a product’s temperature throughout its journey, and sometimes send an alert if the temperature veers too far.

The volume of the global pharmaceutical market has more than doubled in the past ten years. By the end of 2016, the sales volume is forecasted to have risen to nearly € 942 billion.

Recent figures for India, one of the major pharma producing countries in the world, indicate that India’s pharmaceutical industry will grow to $55 billion by 2020. With export of pharmaceutical products to more than 200 countries, India expects to cross the $16.17 billion mark this year. According to Pharmaceutical Export Promotion Council (Pharmexcil), the growth would be around 15 percent and will be driven by formulation exports.

Pharmaceutical airfreight is expected to grow at a faster pace than general cargo. This has led many carriers to start new facilities for this fast growing segment. Airlines have already started ramping up flights out of India. Qatar Airways Cargo, for example, recently announced the launch of the seventh freighter destination in the country to Ahmedabad. Last year, IAG Cargo introduced B787s in its London Heathrow and Hyderabad, Chennai flights. The B787s have helped the pharma industry. The plane’s forward cargo hold has air conditioning, making it ideal for shipping temperature-sensitive pharmaceutical products.

For their part, airport authorities have brought in equipment and created facilities at some of India’s major international airports. Two airports—Mumbai International Airport (MIAL) and Delhi International Airports Ltd. (DIAL)—have upgraded the air cargo facilities to handle 80-90 percent of the export and import trade of pharmaceuticals.

In association with the Organisation of Pharmaceutical Producers of India (OPPI), the custodians of the two airports have taken initiatives to do away with the bottlenecks that delay the transport process. Among the enhancements are the creation of cold room space, training and refresher courses for the staff that handle pharma products at the airport, and storage.