RESEARCH TRIANGLE PARK, N.C., — With the rise of cell and gene therapies, ushering in a new era of innovation in the biopharmaceutical industry, Marken has teamed up with TrakCel to advance its management and tracking of the many stages of the cell and gene therapy supply chain.

Cell and gene therapy is a new technology targeting difficult to treat diseases by using a patient’s own genes, tissues or cells (or those of a donor) as key ingredients in the manufacture of a new medicinal therapeutic agent.  After manufacturing, many of these agents are either personalized or donor-recipient matched, temperature sensitive, and in most cases are irreplaceable.  In addition, the personalized nature of these treatments requires a “Chain of Identity” for each batch to ensure the treatments are used only by the intended patient.

The clinical supply chains required to handle these treatments are arguably the most complex in the industry, and Marken, with corporate headquarters in Durham, has made investments to supply these services.  As such, technology plays a key part in the supply chain, and Marken has chosen TrakCel “to deepen capabilities in this category of services”.

TrakCel has developed integrated technology to easily orchestrate the cell therapy supply chain for autologous and allogeneic therapies.  The software tracks patient and donor registration, material collection, manufacture, shipment data and final patient infusion details. The interface between TrakCel’s and Marken’s operating systems allows users to automatically schedule or amend material collections in line with manufacturing capacity and each healthcare provider’s treatment schedules. Clinicians are then able to view the progress of therapies through each stage of the supply chain with a single, integrated system.

“The collaboration between Marken and TrakCel is a natural next step in our strategy to expand Marken’s service offerings into the cell and gene clinical supply chain market,” Wes Wheeler, Chief Executive Officer for Marken said in a statement.

“Our network of 49 global sites now include eight cryogenic (LN2) service stations and a very large and well-distributed fleet of specialty shipping containers to serve these trials.  We also ensure 100 percent of all cell and gene shipments travel with our GPS tracking technology and are monitored by our 24/7 Global Control Center.  We look forward to our new collaboration with TrakCel and what we can achieve together.”

“Success in cell and gene therapy development and commercialization relies on close collaboration between industry partners,” Ravi Nalliah, TrakCel’s Chief Executive Officer, added in a statement. “Our collaboration with Marken further enhances the level of needle-to-needle visibility and control that clients can achieve through TrakCel’s software. Importantly, this integration is not dependent on any specific client’s infrastructure. The benefits of our collaboration are available to all clients without the time and cost associated with custom integrations, saving the client valuable resources, and is scalable on a global basis.”

Marken is a wholly owned subsidiary of UPS and offers a GMP-compliant depot network and logistic hubs in 49 locations worldwide for clinical trial material storage and distribution.

Meanwhile, TrakCel is a designer, developer and deliverer of integrated technologies specifically created in 2012 to manage the international autologous and allogeneic cell, gene and immunotherapy supply chain. The company’s platform accelerates global scale-up and scale-out of cell and gene therapy products, increasing efficiency and decreasing complexity, while maintaining needle-to-needle compliance and traceability, and is headquartered in Cardiff, Wales, UK with US offices in California and New Jersey.