Cell and gene therapies are the next-generation healthcare protocols, and the human trials into their efficacies are rising. An advanced supply chain solutions provider is the key to success.
Health science and pharmaceutical therapies have accelerated to the degree that cures for many diseases are within closer reach. And it’s not just the research team wholly responsible for the progress, supply chain solution experts perform critical roles in modern healthcare and quality of life.
According to ClinicalTrials.gov (as of September 2018), there were 304,535 studies underway in all 50 states and in 208 countries. Further, as of May 1, 2019, there were 50,185 studies in active recruitment, and registered studies involving drugs or biologics numbered 137,742. Additionally, a rapidly growing area of targeted healthcare, cell- and gene-based therapies, is seeing more clinical work – more than 1,000 clinical trials in this area were active as of the end of 2018, according to the Alliance for Regenerative Medicine, which noted that this is an increase of 63% in three years. Regenerative medicine trials focusing on various cancers has bloomed to 132% during this time period.
Studies rely on previous research work – and previous data that informs and/or substantiates the discussion and the outcomes. And all too often, time and temperature can make a crucial difference in the analysis of human clinical trial data from samples that may be affected by exogenous factors. For example, nearly two-fifths of the biopharma pipeline is now composed of temperature-sensitive biologics and antibodies, and further, there is an upswing in gene, cell and other more highly advanced therapies that are even more vulnerable and challenging to transfer.
Gene and cell therapies represent a new arena of biopharmaceutical innovation, targeting conventionally difficult to treat diseases by using the patient’s (autologous) or donor’s (allogeneic) cells, tissues and/or genes as the raw material to create new medicinal/therapeutic agents. After manufacturing, they are either personalized or matched to the donor-recipient. They are also highly temperature sensitive, and irreplaceable.
Cell and gene therapies, therefore, require a chain of identity for each batch to ensure they are to be used only by the intended patient. “The clinical supply chains required to handle these treatments are arguably the most complex in the industry,” observed Wes Wheeler, Chief Executive Officer of Marken. Marken is actively working to develop advanced IT solutions that facilitate scheduling within the cell and gene therapy supply chain. They are collaborating with a company which has developed integrated software technology that effectively and easily orchestrates the cell therapy supply chain for autologous and allogeneic therapies. The interface between them 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.
This collaboration, Wheeler asserted, expands Marken’s capabilities in the cell and gene clinical supply chain market. Its network of 49 global sites now include nine cryogenic (LN2) service stations and an expansive, strategic fleet of specialty shipping containers to serve these highly sensitive trials. “We also ensure 100% of all cell and gene shipments travel with our GPS tracking technology and are monitored by our 24/7 Global Control Center,” he added.
Overall, ensuring chain of identity and visibility of shipments from donors and patients to manufacturing site to point of care is critical; protecting clinical materials from point of origin through transit and to use is a singular priority. It’s essential to your supply chain process to select an experienced provider that will collaborate at the early stages of the process to review potential risk points, establish contingency plans, and safely deliver specialized therapies to sites and patients around the world.
As another example, a small but important Phase II European multi-center study of 100 pediatric patients with leukemia necessitated the international pharmaceutical company team to obtain T-cells (through apheresis) and ship them from patients to US manufacturing sites at 2-8 ºC within 28 hours for manufacturing via cryopreserved leukapheresis but typically, cryogenic shippers require one week of validation time to ship from the US to Europe; the time to reach the investigator sites in Europe and back was therefore prohibitive. In addition, cryogenic shipper rental companies are regional, not global, and generally do not operate 24/7.
Marken mobilized a team to sort out and truncate the complex logistics process, beginning with arrangements for a steady supply of cryogenic shippers. The team also created viable contingency plans that considered all local and national regulations and Ministry of Health guidelines for each region where the product was shipped. Because Marken’s solution worked to deliver on time and in spec, the therapy received approval from the FDA and can now potentially bring positive results to more patients.
Throughout the increasingly sophisticated requirements for effective, safe transfer of vulnerable and sensitive biological and pharmaceutical materials, packaging serves as a crucial factor beyond just being a protective envelope. Marken’s new Smart Box affords complete monitoring while ensuring contents are undenatured during transit. Smart Box is a thermal configurable container designed to provide optimum protection for high value shipments of clinical drug products, clinical drug substance, and cell and gene therapies. It provides 24/7 tracking visibility using any one of three available GPS tracking devices -- including Marken’s SENTRY device that provides location, temperature, movement, and shock as often as once per hour. The box can also accommodate Bluetooth technology for temperature monitoring and identification, and it has been extensively thermal tested in compliance with industry standards for up to 96 hours at 2-8 degrees C, including Analytical Thermal Modeling Software (ATMOS)-enabled lane simulation scenarios.
“At the same time,” Wheeler related, “we are increasing our fleet of Sentry GPS tracking devices and have placed additional orders for thermal packaging to supplement the new Smart Box. The combination of our existing fleet of thermal packaging and our new fleet of Smart Box containers, together with a variety of GPS trackers, will give our clients many options to secure and protect their valuable shipments.”
Often, technologies synergize with one another to augment the quality of an outcome, and in packaging, Marken’s newly added Roambee monitoring technology provides heightened endto-end visibility throughout the supply chain for valuable clinical product shipments. Roambee devices are affixed to Marken‘s packaging fleet allowing shipments to be more visible at certain staging locations throughout the clinical supply chain.
Roambee real-time monitoring technology accelerates growth and expansion for shipment visibility. Marken’s packaging fleet equipped with Roambee sensors allows the company to continuously scan, identify, locate and re-deploy assets faster and more cost effectively, as well as monitor the location, condition, and security of products. This integrated solution meets industry qualification standards for data integrity and temperature assurance and will provide added visibility within the Marken network.
This technology is flexible to allow for even the smallest of packages to be transported, no matter the kind, size and value of shipment. Through its next-generation innovations, Marken can provide instant details to clients who need to know, in real time, that a definitive delivery date has been met.
“We have seen an incredible growth in the number of sensitive shipments that demand real time tracking and we understand that clients expect tracking technology for shipments of any value in today’s industry,” said Wheeler. “As the value of clinical products continues to climb, our goal is to provide an unprecedented level of supply chain security.”