Learning Center

Mastering the Advanced Therapy Supply Chain
The field of Advanced Therapy Medicinal Products (ATMPs) has seen monumental advancements in recent years, offering groundbreaking treatments for a wide range of serious diseases. In the accelerated development of new modalities, the distribution and storage of these ultrasensitive medicinal materials presents unique challenges due to their complex nature and stringent regulatory requirements.
As a specialty precision logistics provider, Marken’s expertise in ATMP distribution is led by our Advanced Therapies Division (ATD) — an expert team with an extensive background in science and logistics. Their experience covers many aspects of the ATMP journey, from specialized equipment and strict handling protocols to hands-on commercial biomanufacturing and clinical research and development (R&D). Our team handles some of the most life-critical medicines, from cell and gene therapies (CGT) to nucleic acid therapies (NAT), and the raw materials used to manufacture them, such as vectors, cell lines or leukapheresis units. These therapies require strict temperature control, real-time visibility, and precision logistics to ensure that every patient receives their therapy on time and within specifications.
At Marken, we understand each shipment represents a ray of hope for patients, many of whom have exhausted other treatment options. Time is critical, and our ATD team is laser-focused on maintaining product integrity with quality and precision, delivering white-glove service from vein to vein. With a global network of resources, state-of-the-art facilities and advanced packaging solutions, we ensure storage and distribution of these life-saving therapies with full visibility and control over temperature and transportation conditions.
Game-changing logistics for groundbreaking medicines
Recent innovation and strategic partnerships have amplified the ATD team’s ability to elevate solutions for the delivery of cutting-edge therapies. To facilitate operational excellence with complete visibility, our 24/7 advanced therapy control towers monitor the condition and location of shipments leveraging advanced data logging technology. These features are an integral foundation for the ongoing evolution of logistics, delivering the next generation of on-demand, ultrasensitive medicines. Marken continues to invest in both people and future-focused cold chain technology to meet the dynamic needs of ATMPs.
Marken is committed to continuous technological advancements and integration. Sensors with Internet of Things (IoT) capabilities raise the bar on reaction times, and when enabled with artificial intelligence (AI), offer significant improvement to the supply chain’s ability to quickly adapt in emergencies and potentially automate select processes. Along with these technology breakthroughs, Marken’s best-in-class Quality Management System (QMS) and inventory control platform monitor conditions for each environment, facilitating enhanced visibility, tracking, and more expeditious contingency plan implementation in the event of a deviation, temperature excursion, or an emergency.
Supply chain collaboration for unmatched efficiency
Collaboration between stakeholders, including sponsors, contract development and manufacturing organizations (CDMOs), clinicians, patient advocacy groups, air and ground freight providers, outside service providers, and regulatory authorities, has streamlined processes for ATMP movement, further accelerating timelines for clinical development and commercial approvals. Marken’s ability to remain resilient and responsive amidst the exponential rise in the ATMP market, which is predicted to grow by a CAGR of 18.92% over the next 10 years1, has been instrumental in our industry-leading success in this field. These relationships are imperative, as ATMPs traverse a complex matrix of logistics movements between critical manufacturing steps, quality control checks, customs checks, and regulatory approvals throughout their journey. The ATD team plays a pivotal role by securing the storage and logistics movements of these products during their tenuous journey from bench to bedside. The specific nature of these therapies leads to longer lead times and the increased risk of disruption — delays avoidable with proper expertise, communication and flexibility in the face of uncertainty and adversity.
The close relationships Marken’s ATD team has established with key outside stakeholders enables unique capabilities in developing detailed plans, risk assessments, and routing to accommodate the particular needs of each ATMP journey. Marken’s proactive project management teams meticulously map out each lane of the shipment journey and carry out a detailed needs assessment to ensure a customized delivery solution, as well as training of drivers and staff for specialized patient and client needs. For projects where therapies require immediate transport to the patient upon booking, the ATD team creates a detailed project plan to deliver immediate action when notified. In the weeks prior to first live shipments, the ATD team performs mock shipments to rigorously test lane mapping and client operating procedures (COPs), identifying any potential flaws to ensure they are optimized for effectiveness, efficiency, and flawless execution during the live shipment.
Building infrastructure for the future of healthcare
Marken continuous to expand our global infrastructure and cryogenic network to accommodate the rapid growth of the ATMP space – leading the way into a new era of healthcare, a future where highly advanced and personalized medicines are available to support patients on-demand. This includes dedicated operational hubs in key locations, control towers globally to monitor and mitigate disruption, LN2 filling stations, and packaging conditioning hubs. Our Early Access Program (EAP) experts work closely with the ATD team to enable more widespread access and adoption of these therapies in underserved areas as well as supporting prior to market approval. Marken recently also invested in a multi-million-dollar, state-of–the-art Advanced Therapy Center of Excellence in Amsterdam, Netherlands, offering comprehensive storage and distribution solutions for ATMPs globally. As the clinical precision logistics and advanced therapy subsidiary of UPS Healthcare, Marken has orchestrated thousands of ATMP shipments around the globe, often navigating serious disruption, while building on winning strategies necessary to deliver vital therapies.
While the distribution of ATMPs presents challenges unique to their sensitive nature and complexity, recent advancements in technology, supply chain optimization, and a deep understanding of the regulatory processes for ATMPs, has allowed Marken’s ATD team to mitigate and overcome these challenges to ensure patients have access to life-altering or life-saving treatments. As the field of ATMPs continues to evolve, it is essential supply chains evolve alongside them by investing in technology, people, and robust distribution networks to meet the growing demand worldwide.
Contact us today at expert@marken.com to learn how Marken can optimize your global advanced therapy supply chain to deliver tomorrow’s lifelines.
Understanding why we must adapt, continuously asking ourselves how we can change what matters is how we keep on delivering it.
Login and quick links