Manufacturers

Customizing the Cold Chain

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The growing need for targeted temperature-control solutions.

Market summary

098_WC_Article _Imgs _r 1-03Of all the statistics emerging around the global pharmaceutical industry this year, two big numbers capture the attention of both manufacturers and their logistics partners: $248 billion, the amount the "BRIC" nations (Brazil, Russia, India and China) are poised to account for in pharmaceutical sales for by 2016i; and $8 billion, the amount global pharma will spend on cold chain logistics in 2014ii.

Why are these two numbers so noteworthy? They demonstrate that as R&D goes, so goes logistics. As products evolve to meet demands for more targeted therapies, demand for more targeted logistics solutions grows as well. And that means a need for customization for everything from clinical trial samples to finished product.

Understanding these market dynamics requires a closer look at what is going on across the pharmaceutical continuum - and where manufacturers can find solutions that meet their temperature control needs.

Drug trends drive new temperature demands

The days of the blockbuster drug are waning. New products - in terms of both development and commercialization - are moving toward more targeted therapies and second or third-line use and customized treatments for rare disease.

Drugs are evolving to contain more and more high-value active pharmaceutical ingredients that have shorter shelf lives and strict temperature requirements. In addition, there has been an uptick in demand for "body temperature" transportation for medications that are developed by taking the body's own substances, such as cells and blood, modifying it and dispensing the "processed" substance to the patient. Transit time for products like these is usually a maximum of 36 hours. And as GDP/GTP regulation continues to require temperature control with monitoring during the whole supply chain, logistics partners are also beginning to see more requests for Controlled Room Temperature (CRT). In light of these market dynamics, it does seem that not everything is "cold" anymore, hence the movement to the all-encompassing term temperature control.

Packaging innovation

While in-flight GPS monitoring is taking flight and airports are starting to provide separate cold storage for pharmaceuticals, manufacturers still cannot rely on the supply chain alone. As such, the ability to pack for varying temperature ranges is evolving to meet diverse product needs. Almost all packaging manufacturers are developing vacuum insulated panels (VIP) and phase change material (PCM) solutions that allow for easier handling and storage of temperature-controlled products and samples. This is a marked move away from semi-active solutions - a mix of frozen and cooled water-based gel packs - to pure passive solutions with PCMs. The new host of offerings and solutions means a multitude of choices when it comes to choosing the right packaging for a particular product.

Cool solution

Manufacturers must recognize that not many airports around the world offer a true temperature-controlled storage solution. While airports may offer cold rooms, temperatures inside those storage areas can range from +-0°C up to +13°C. The same goes for CRT - it's often too cold or too hot. Partnering with logistics companies that have a network of local knowledge and contacts and using the right packaging from the start can mitigate temperature excursions. Manufacturers should ask themselves whether their service provider has the ability to change or replenish PCM during transport or storage, remembering that the use of qualified packaging can provide maximum independency within the supply chain.

While new technologies in VIP/PCM most certainly make temperature-controlled transport easier, manufacturers still need the expertise and control that comes from choosing the best solutions for their needs. That can include considerations for the route and correct preconditioning of PCM, correct labeling of the system and a properly configured and positioned temperature monitor, along with the control function that the box is stored in and the environment and storage before delivery. All of these aspects should be custom considerations with solutions aligned to the manufacturer's goals. In addition, having a reliable partner present during pickup (loading the product) and delivery (unloading, storage of the product) can make all the difference.

The regulatory environment and other global concerns

The impact of Good Distribution Practice (GDP) on temperature-controlled transport continues to grow. In short, GDP emphasizes temperature control during the whole supply chain-no transport without temperature monitoring. As it relates to pharmaceuticals specifically, GDP addresses Quality Management Systems (QMS) and documentation, personnel and training, risk management (including SOPs), facilities/storage, transport and much more. Due to increasing regulatory requirements, quality departments within manufacturers' supply chain operations are gaining more and more influence. This, coupled with the complexity of regulatory compliance, means that various stakeholders on the manufacturer end must ensure that suppliers and transport partners comply with applicable regulations, taking a risk-based approach and enforcing audits and quality agreements.

There are also continental and country-specific regulations to consider when a manufacturer is running clinical trials in emerging markets. Latin America encompasses 20 individual countries, each with its own import/export regulations, while the surge of clinical trial applications in Mexico recently has created delays and backlogs. And in Brazil, import licensing can be complicated on top of trial approvals that can take months.

China presents specific temperature-control challenges, as packages are often selected for customs inspections that require removal from controlled storage areas. Navigating Singapore's regulatory and tax requirements can be complex without the right knowledge of simplified storage for supplies. All of these issues are just a glimpse at how global regulations can become roadblocks for manufacturers.

From political unrest to pandemic concerns, the possibility of changes in shipping patterns and/or logistics strategies is quite real. Shippers face no service at all to and from Cuba, Iran, North Korea and Syria, as well as sanctions for Russia and Ukraine. In addition, complex restrictions for specific commodities and/or companies/persons exist for countries such as Belarus, Myanmar, the Ivory Coast, Iraq, Libya and more, meaning global transport strategy becomes wholly difficult to navigate. Moreover, the concern over Ebola means manufacturers also face issues like dangerous goods certification, IATA/ADR regulations and flight restrictions. More and more, manufacturers are challenged with having to be experts in political issues that impact logistics.

Partner for peace of mind

Regulatory compliance doesn't need to be a manufacturer's core competency. The most reliable logistics partners have the experience to execute customized cold chain logistics based on market-specific knowledge, regulatory expertise and product profile. From GDP compliance and customer-centric SOPs to local resources and relationships, partner with a provider whose practices expedite and enhance the global clinical trial process, ensure product quality and integrity, minimize risk, increase efficiency and optimize the supply chain. The most successful stakeholders will be the ones that can take key lessons learned from previous events and apply them swiftly in the face of new crises to maintain a seamless supply chain.

Where customization makes the most impact

There's no question that shifts in market dynamics, innovation and the global landscape mean manufacturers are dealing with new complexities when it comes to specialty transport. And factoring in temperature control makes decision-making even more complex. Perhaps that's why we're seeing the spend on cold chain logistics grow, but most certainly there is value in the spend. Custom solutions for temperature-controlled transport come with consultative approaches to packaging solutions, in-market knowledge and local resources with high-touch handling, as well as regulatory expertise. Involving specialty logistics partners in the early stages of clinical trial planning also offers cost- effectiveness as manufacturers reduce the likelihood of having to revisit packaging scenarios when a solution could be tailored to product and/or supply needs. After all, finding the right temperature-control solution can mean getting the right product to the right patient at the right time - moving medicine forward and getting the right return on R&D investments.

iMS Health, The Global Use of Medicines: Outlook Through 2016. July 2012. Available online at http://www.imshealth.com/portal/site/imshealth/menuitem.18c196991f79283fddc0ddc01ad8c22a/?vgnextoid=9da5e590cb4dc310VgnVCM100000a48d2ca2RCRD&vgnextfmt=default. Accessed 7 November 2014.
iiLipowicz, M and Basta, N. 2014 Biopharma cold chain forecast. Pharmaceutical Commerce. 29 April 2014. Available online at http://www.pharmaceuticalcommerce.com/index.php?pg=supply_chain_logistics&articleid=27206&keyword=biopharma-cold%20chain-logistics-forecast. Accessed 30 October 2014.

 

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