Rewriting the Playbook on Cold Chain Packaging

In today’s pharmaceutical landscape, where temperature control is mission-critical and timelines are tight, cold chain logistics has taken center stage. The rise of personalized medicines and complex biologics demands not just precision but also flexibility and sustainability. Marken, UPS Healthcare Precision Logistics, is tackling these challenges head-on through innovative solutions like its Packaging as a Service (PaaS) model—an offering that streamlines access to high-performance, reusable packaging while reducing waste and cost.

In this Q&A, Mike Bartone, Vice President of Global Cold Chain Solutions Management at Marken, discusses the company’s approach to modernizing clinical logistics. From leveraging real-time monitoring and predictive analytics to scaling Marken’s PaaS program across global markets, Bartone outlines how the organization is building a smarter, more resilient cold chain—and what that means for the future of clinical trials and patient care.

Contract Pharma: How has the pharmaceutical contract packaging landscape evolved in recent years, particularly with the rise of temperature-sensitive and personalized therapies?

Mike Bartone: The pharmaceutical packaging landscape has undergone a dramatic transformation, driven primarily by the growth of personalized medicines and temperature-sensitive therapies. Traditional methods, designed for high-volume products, now require greater flexibility, precision, and speed. Marken’s Packaging as a Service (PaaS) is uniquely positioned to meet these evolving demands by providing immediate access to pre-qualified packaging solutions, real-time inventory visibility, and customized, scalable options. Our solutions maintain strict control across the full spectrum of temperature ranges—from ambient to cryogenic – ensuring product integrity, compliance and patient safety from point of origin to final mile delivery.

CP: What are some of the biggest challenges pharmaceutical companies face when managing packaging internally or through traditional third-party vendors—and how does Marken’s Packaging as a Service (PaaS) model help overcome them?

Mike: Pharmaceutical companies often struggle with stock-outs, inflexible packaging options, insufficient cold-chain expertise, and regulatory compliance complexity. Another significant challenge is the qualification process required to onboard new packaging solutions—the time, resources, and effort needed to ensure that new systems meet stringent internal and regulatory standards can be rigorous and often slows down innovation.

Marken’s PaaS model directly addresses these pain points with a holistic, streamlined solution. Marken provides global inventory planning, refrigerant storage and conditioning, shipment coordination, and reverse logistics. Clients benefit from immediate access to validated packaging, centralized inventory visibility, real-time tracking, and end-to-end compliance management, eliminating disruptions and significantly reducing operational costs and risks.

Marken also brings deep expertise to the qualification process. We have begun developing and writing qualification protocols and executing qualification testing on behalf of our clients. By leveraging Marken’s services, clients can rely on our ability to evaluate all products in the market included in our catalog, ensuring that only the most effective, best-in-class systems are recommended for their supply chain. This means clients avoid the time-consuming and resource-intensive process of qualifying systems that may not ultimately meet their needs. In short, Marken makes what is typically difficult and time-consuming both efficient and effective, removing barriers and accelerating the path to optimal packaging solutions.

CP: Marken emphasizes a packaging-agnostic approach in its PaaS offering. Can you elaborate on how this benefits clients compared to a one-size-fits-all model?

Mike: Marken’s packaging-agnostic approach offers clients distinct advantages by prioritizing flexibility, quality, and tailored solutions over restrictive, proprietary models. Here’s how this benefits clients:

Access to the best-fit solutions: By remaining agnostic, Marken draws from a network of over 1,500 pre-qualified packaging options, ensuring that clients receive solutions precisely matched to their therapy’s temperature stability, transit duration, regulatory requirements, and sustainability objectives.

Quality without compromise: While Marken’s approach allows for the “best option to win,” it never sacrifices quality. Every recommendation undergoes rigorous evaluation to proactively mitigate risk and ensure that only solutions that fully meet the client’s needs and safety standards are put forward.

Enhanced flexibility: Clients are not limited to a single proprietary system. Marken’s adaptable model enables them to select from a broad catalog, ensuring each packaging solution is customized specifically to each client’s unique requirements – without compromise or unnecessary risk.

Real-time tracking devices: Marken’s integrated solutions network extends beyond packaging to include monitoring devices. This enables a tailored approach to shipment visibility, offering both live tracking and post-shipment data-driven analytics based on the client’s specific needs.

Operational efficiency and reduced risk: The ability to select from a wide array of validated solutions reduces operational risk and ensures optimal packaging performance and cost-effectiveness, no matter how complex or unique the client’s requirements may be.

In summary, Marken’s packaging-agnostic approach empowers clients with rapid access to the most effective, reliable, and compliant solutions—making their supply chain both resilient and responsive, while maintaining the highest standards of quality and risk management.

CP: With global clinical trials and commercial launches on the rise, how does Marken ensure scalability and just-in-time packaging availability across geographies?

Mike: Marken’s approach combines strategic forecasting, asset optimization, and leveraging UPS Healthcare’s unmatched network to maintain readiness and responsiveness worldwide. Our advanced network includes strategically located facilities and optimized inventory positioning, enabling rapid and precise deployment tailored to fluctuating clinical and commercial demands, significantly reducing lead times and enhancing geographic responsiveness.

CP: What role does real-time tracking and centralized inventory visibility play in Marken’s PaaS model, and how do these features enhance risk mitigation for clients?

Mike: Real-time tracking and centralized inventory visibility are pivotal to Marken’s PaaS offering, significantly enhancing client risk mitigation capabilities. Our real-time enabled trackers and advanced digital monitoring systems provide continuous visibility of shipment conditions, including temperature, location, and chain of custody. This level of transparency enables proactive inventory management and immediate responsiveness, minimizing risks related to temperature excursions, inventory shortages, or delays, thus preserving product quality and reliability.

CP: How does Marken’s PaaS model support sustainability initiatives in pharmaceutical packaging, particularly when it comes to reuse, refurbishment, and reverse logistics?

Mike: Sustainability is deeply embedded in Marken’s PaaS model, which is designed to maximize reuse, refurbishment, and reverse logistics for pharmaceutical packaging. We extend the lifecycle of every packaging asset through meticulous inspection, cleaning, and requalification processes – reducing waste and minimizing environmental impact. By optimizing each step of the packaging journey, we help clients cut carbon emissions, lower costs, and meet sustainability targets without compromising quality or compliance. Beyond this, we are constantly innovating, introducing greener materials, enhancing reverse logistics efficiency, and investing in technologies that reduce our overall footprint. Marken is dedicated to not only supporting our clients’ environmental commitments but to set new industry standards for sustainable, future-ready cold chain packaging.

CP: Can you walk us through the process of how Marken validates packaging solutions—from qualification to conditioning, storage, and eventual deployment?

Mike: Marken’s rigorous validation process involves comprehensive supplier qualification, intensive performance testing under real-world scenarios, and adherence to strict GDP standards. Validated packaging undergoes precise conditioning protocols and strategic storage at global facilities for immediate availability. We maintain stringent documentation for each step, including conditioning records, qualification reports, and temperature logs, ensuring continuous compliance and reliability from initial qualification through to patient delivery.

CP: How does Marken’s integration with the broader UPS Healthcare network enhance its Packaging as a Service solution in terms of operational reach and responsiveness?

Mike: Integration with UPS’s Healthcare global network significantly amplifies Marken’s operational reach and responsiveness. With limitless infrastructure and expanded capabilities – this facilitates seamless coordination of packaging assets, reduced transit times, increased operational agility, and unmatched reliability, vital for the timely and secure delivery of critical pharmaceutical therapies and healthcare innovations.

CP: Given the regulatory scrutiny around temperature-controlled shipments, how does Marken maintain GDP compliance and quality assurance across its PAS infrastructure?

Mike: Marken maintains strict GDP compliance through robust Quality Management Systems (QMS), detailed Standard Operating Procedures (SOPs), rigorous team training, regular audits, and meticulous documentation practices. Each packaging solution and shipment is monitored continuously, and validated performance is preserved through formal change control processes, ensuring compliance, regulatory alignment, and uncompromised quality across our entire PaaS infrastructure.

CP: Looking ahead, how do you see the role of Packaging as a Service evolving in the face of increasing demand for cell and gene therapies, radiopharma, and other high-value biologics?

Mike: With rising demand for advanced therapies, nuclear medicines, and high-value biologics, Marken’s PaaS will become even more essential to the pharmaceutical supply chain. Marken is committed to consistently incorporating increasingly innovative real-time monitoring technologies, predictive analytics, smart packaging solutions, and advanced asset management strategies. These enhancements will enable Marken to maintain the precision, speed, and flexibility, qualities that are critical for the safe and reliable delivery of complex, sensitive therapies to patients worldwide.

Marken’s unique position in the market as a trusted precision logistics provider, combined with our in-depth understanding through our product-aligned structure, we are positioned to seamlessly integrate continuous innovation. We actively push the boundaries of what exists in the market today, striving to solve real-world challenges faced by our clients. This means not only keeping pace with the evolving landscape of advanced therapies but also anticipating future needs, ensuring that our PaaS offering remains at the forefront of quality, compliance, and technological advancement for years to come.

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