The vibrant and growing pipeline of cell and gene therapies (CGT) provides many exciting clinical opportunities for patients and their physicians, and many financial opportunities for today’s innovative pharmaceutical companies. Whether the treatment uses autologous or allogenic production, all cell and gene therapies have complex requirements when it comes to the specialty packaging and chain-of-custody transport of both biological material used in manufacturing and the resulting therapy used to treat the patient.

Early involvement with approved CGT treatments has allowed the cold chain industry to develop a successful shipping and logistics methodology, and best practices are beginning to emerge thanks to a growing body of collective experience. However, most of today’s winning strategies related to temperature-controlled packaging, shipping and logistics management have been proven on a very small scale — often related to the management of just one patient’s biological materials or CGT product in a single highly coordinated delivery routine.

As successful CGT providers ramp from clinical development through commercial launch to large-scale market uptake, the cold-chain shipping needs will grow – perhaps from just a few shipments per week to hundreds or even thousands of shipments per week. The question on every pharma producer’s mind should be: “Can the existing delivery infrastructure scale over time, and can our current cold chain partners grow with us in terms of growing volume and global reach?”

Organic growth of the cold chain is not sufficient

As this vibrant section of the healthcare arena continues to grow, and the CGT pipeline continues to mature, all stakeholders in the space need to be thinking about and planning for scaleup, as early as possible in the product’s commercial lifecycle. Rather than just letting organic growth happen — and then potentially getting caught off guard by gaps in the cold chain packaging and shipping infrastructure — pharma companies should conduct their due diligence at the earliest opportunity to select cold chain packaging and logistics/freight forwarder partners that have the expertise, experience and global footprint to grow with the brand and handle future volume expansion seamlessly.

Due diligence considerations

As pharma companies work to evaluate potential partners to support the commercial success of their CGT offerings and identify best-in-class providers, they should consider these critical questions:

• Does the company have the resources, experience and partnerships needed to move high-value, time- and temperature-sensitive raw materials and finished CGT products across the globe?
• Is the company appropriately resourced to meet growing volume demand?
• Does the company have a global footprint including staff and service centers that can provide rapid response and troubleshooting for the temperature-controlled shipping containers?
• Does the company have an established network of local partners all over the world to help manage “the last mile” of the journey and avoid delays that could threaten the integrity of the product?
• Is the shipping container supplier able to provide all forms of temperature-controlled packaging (active and passive, long- and short-duration, small/hand-carry parcels and bulk containers) to meet the pharma company’s evolving needs?
• Does the container provider offer GPS tracking by container as well as monitoring for other key metrics such as temperature inside and outside the package? Does the company provide access 24/7 access to the monitoring platform to enable all stakeholders to assess the status and respond quickly, should issues or delays arise?
• Can the provider(s) easily conduct pilot-scale operations to evaluate various packaging and delivery configurations?

It’s never too early to plan for market expansion

Within the CGT space, a considerable amount of time and effort is spent on the early clinical development, regulatory approval and early product-launch phases. But there is so much more than just getting the product out the door. Today, most pharma companies are not spending enough time and effort early in the launch process to both envision and enable larger-scale commercial operations, especially regarding the need to reliably manage cold chain packaging and transportation requirements. Failure to identify suppliers and logistics partners that offer best-in-class capabilities — from the product or service offering to training programs, customer-service, continuous process improvement, and overall data-management practices that ensure quality and reliability of every shipment — signals a missed opportunity. The goal is to create a comprehensive and well-designed cold chain packaging, transportation and delivery infrastructure that will grow with your product. A strategic approach will bring tactical efficiencies, overall economies of scale and increased reliability that are not always possible when an infrastructure is created from a patchwork of options added over time.

The ability of any pharma company to establish strong, collaborative partnerships with proven cold chain packaging and logistics providers is essential to safeguarding critical CGT payloads through every step of the supply chain, while increasing volume and expanding geographically. The ability to establish a network of proven packaging suppliers and freight-forwarding partners ensures reliable chain-of-custody management of these critical packages — every time.