The world’s first allogeneic T-cell therapy — a type of universal immunotherapy treatment that relies on donor blood — was approved in Europe earlier this month. Not only is this a game changer for the medical industry, it demands innovation from the logistics industry as well.
With this scientific leap, the possibility of having a single large batch of engineered cells to potentially treat hundreds of patients is becoming a reality.
Cold chain logistics is a relatively niche industry, and the number of providers that have experience with cryogenic shipments is even smaller. Cell and gene therapy cryogenic logistics needs to grow at an increasing pace. About 1,000 CGTs are in development and clinical trials, according to “Global Advanced Therapy Medicinal Products Market 2021-2028” Research and Markets. According to CGT companies, trials and therapies will not advance without third-party logistics partners providing a global network of cryogenic capabilities.
Integrated Commercialization Solutions (ICS) has been handling critical, cutting-edge pharmaceutical shipments for more than a decade. The company, which is part of AmerisourceBergen’s cell and gene therapy ecosystem – has spent years investing in the infrastructure needed to move these types of treatments at a large scale.
ICS, and its sister companies, bring expertise in each area required for successful commercialization, whether it is patient support services, strategic consulting, product sourcing and supply chain management, or global specialty logistics.
While the tools and expertise the company has developed are not yet required on a large scale, that is expected to change. The company is ready to respond when it does. As part of their commitment to meet our customers’ evolving needs, they’ve invested in the cryogenic storage infrastructure, proven methodologies and processes that enable partners to scale their specialty product from many to millions.
“We have infrastructure today we think is viable for the projected volume level, and we have built out future plans that allows us to expand to more automated options as the industry evolves,” said Albert Cooksey, senior vice president and general manager of 3PL services at ICS.
Baked-in flexibility is a cornerstone of the ICS approach, allowing the company to flex its resources based on business model and product, provider, and patient needs. This is essential not only in response to market evolution but also when executing each individual shipment.
Utilizing these therapies is a multistep process that can change at a moment’s notice. Additionally, these products are extremely sensitive and remain viable for only a small window of time, often as little as 24 to 72 hours. This combination makes adaptability and coordination crucial skills that logistics companies must have to safely and efficiently deliver these innovative therapies.
“The biggest challenge is trying to coordinate all the moving parts, along with the patient administration,” Cooksey said. “Those things all have to come together as part of this process.”
Coordinating the moving parts includes working in lockstep with both manufacturers and receiving facilities, creating standardized protocols that keep everyone on the same page, and providing a guidebook for handling mishaps or disruptions.
Having these policies and procedures in place before moving these shipments is a crucial part of ensuring that the product remains a safe, viable treatment for the patient in question. That means education and collaboration efforts need to start now and include every link in the supply chain.
In order to do this, manufacturers should partner with 3PLs early, including them in every step of the planning process. This allows them to assess the 3PLs abilities and understanding surrounding the product, as well as its capacity. It also allows manufacturers to get as much out of the partnership as possible.
“Take advantage of all the services offered by a 3PL to take some of the complexity out of your supply chain. Use the 3PL as much as you possibly can,” Cooksey said. “Additionally, bring together the transportation operations so everyone understands all the moving parts and can be made aware of idiosyncrasies and alternative plans.”
Allogeneic T-cell therapies are brand new, which means there is no existing rule book when it comes to moving them. Because of this, companies across the supply chain should prepare to be all hands on deck when it comes to transporting the first few shipments.
There continues to be tremendous growth across the CGT industry as a whole, doubling down on the importance of preparation and stakeholder collaboration. Every link in the supply chain must work together for these innovative therapies to realize their full potential. This means partners like 3PLs must continue to invest in infrastructure that enable the safe and dependable distribution of these therapies, and every player should commit to early planning to smooth out challenges across the commercialization journey.
ICS, for one, is ready.