The Cold Chain Challenge

Technical Article From Biocair

As pharma would not be able to function without detailed, efficient, flexible and secure cold chains, the future will mean using increasingly sophisticated techniques and technologies to deliver world-class logistical services.

The logistical support the pharma supply chain requires includes a strong understanding of the cold chain. Vaccines, in particular, must be delivered within a narrow temperature range to the end-user to ensure their potency. Ensuring these medicines are effective means understanding the impact that temperature and environment can have on them.

As the pharma landscape continues to evolve, the need for reliable temperature-controlled supply chains becomes increasingly important. Indeed, of the top 50 drugs today, half need a cold supply chain to support them. As biopharma products accelerate, supply chain service providers will have to expand and diversify their services to meet the increasing demand.

Temperature control is more faceted than just maintaining low temperatures. Logistical service suppliers need to offer controlled ambient, refrigerated, frozen, deep frozen and cryo frozen services – each with their own temperature profile and application. Accurately monitoring the temperature of a package as it moves through the supply chain is vital. As some medicines have limited ranges of effective temperature, ensuring a medicine, vaccines or gene therapy is maintained at its optimum temperature is the foundation onto which today’s cold chains are based.

Biocair has a global network of liquid nitrogen service stations and operates its own dewars. All dewars are fully compliant to IATA requirements.

PwC in their 'report' Pharma 2020: Supplying the future’ concluded: “Increasing demand for biologics has stimulated the development of specialist logistics providers capable of handling very sensitive pharmaceutical freight. Many provide specialized service where each shipment is transported in temperature – and humidity-controlled conditions, monitored from a dedicated call centre using web-based tracking and reporting, and delivered directly to the customer's door.”

Also, the creation of new pharma products is rapidly moving towards biopharmaceuticals. Being able to create these products that can often treat previously untreatable or incurable diseases, has meant the supply chain that connects to these products has also had to evolve. According to Pharmaceutical Commerce, the spending on cold chain biopharma logistics will hit USD$18 billion, most which will be spent on air and parcel cold consignment shipping.

Cold Chain Compliance

Often, pharma products will move through several areas of transit. Here, mapping the temperature of these storage facilities is critical. Temperature-sensitive products must have their temperature maintained throughout their transit. Temperature mapping of these facilities is also an on-going exercise that all logistical service suppliers and their partners need to carry out regularly. Cold rooms, warehouses, order assembly points and loading docks all have specific temperature profiles that must be monitored and maintained based on the pharma products being stored or transported.

Having detailed information about a shipment as it passes through the cold chain is vital. A risk assessment analysis reveals any weak points in the chain that must be improved to maintain the temperature integrity of the product being transported. Together with SOPs (Standard Operation Procedures), cold chain service suppliers then have the information they need to deliver high levels of predictability across the supply chains they manage.

The need for detailed shipping information will continue to be vital to create and maintain an efficient pharma cold supply chain, especially as emerging markets become more critical as they expand and mature. Specific challenges are developing to create robust, efficient and secure cold supply chains across growing regions where extreme climate may be the norm.

Cold chain service providers will have to be creative in their approach. The brands they support have clear roadmaps to support these developing regions. Only those cold chain service providers that can deliver logistical innovations at the right price will be sustainable over the long term.

Thermal shipping must meet strict compliance regulations. Here, phase-change materials (PCMs) and thermal modelling tools have developed to provide supply chain providers with passive temperature-controlled packaging solutions of varying sizes and validation times such that the service provider can utilise the most fit-for-purpose solution available.

One of the most critical aspects of creating a reliable cold supply chain is ensuring that the human component has the training and knowledge they need to ensure temperature excursions are kept to a minimum. With most temperature failures caused by human error, it's vital to understand where the risk factors exist across a cold supply chain and mitigate them where possible.

Next-generation cold chain logistics

According to The IQVIA Institute for Human Data Science, the biopharma industry as a whole loses USD$35 billion each year through temperature-control failures across their supply chains.

There are growing regulatory requirements, including serialization, which will see global standards develop. In addition, being able to show that a consignment met its required temperature tolerances door-to-door will also become a pre-requisite for suppliers of cold chain services. 

Transportation across the cold chain has also come under considerable scrutiny over the last few years. The emission concerns, high cost and multiple handling points of air transport have seen a shift to sea. Airfreight will always have a place with time-sensitive consignments. However, the cost of air freight will mean a continued reliance on the sea for bulk consignments shipping. Indeed, the development of passive insulation for packing has meant consignments can travel longer distances between cold store locations without damaging the integrity of the materials being moved.

With biopharmaceuticals increasing the need for sophisticated yet reliable temperature-controlled solutions, logistical service suppliers that can demonstrate their abilities across a wide range of product categories will see their businesses grow. 

As the drive to develop more innovative drugs and gene therapies accelerates, new biologic and biosimilar drugs come onto the market, the need for the supply chains to support them to evolve, has never been more important. Personalized medicine and therapies are also expanding. Producing CAR-T cells, for instance, require small batches that are difficult to scale, yet still, demand robust and efficient logistical support services. Here, target medicine will need targeted supply chains. With a drugs market set to grow to USD$90 billion by 2023, according to Precision Medicine Market, cold chain service providers will have to react.

“Sophisticated biopharma products continue to create and expand cold chain challenges,” concluded the 2019 Biopharma Cold Chain Logistics Survey from Pelican BioThermal. “As the volume and value of temperature-controlled biopharma products continue to grow, biopharma C-suites will increasingly see the importance of rethinking their shipping and logistics strategies.”

The challenge is to create general and bespoke supply chains that can support the widening needs of pharma companies and patients. Pharma 4.0 will embrace the advanced technologies that are developing in consignment tracking, insulation and data communications. Ultimately, cold chain service suppliers will become more sophisticated in their approach, building personalized services that are robust, secure, reliable and agile.

For more information about the pharma cold chain visit www.biocair.com or contact enquiries@biocair.com.

Author

Don Riach, UK Operations Director, Biocair