News

Alex T. Mitchell, VP of Operations, Sentry, discusses the company’s temperature-controlled systems, security measures, tracking technologies & more.

 

 

Since its creation by a team of pharmaceutical, cold-chain management and quality assurance experts in 2005, Sentry BioPharma Services Inc. has served the exclusive needs of the pharmaceutical and biotechnology industries.

Sentry specializes in providing cold chain storage and distribution services to the life science industry with a focus on large molecule pharmaceutical substances that are typically highly temperature sensitive. Sentry’s mission is to deliver compliant, secure and scalable services to healthcare entities that embrace an outsourcing strategy. Protecting product integrity is its focus as it delivers life-saving drug products into and out of forty-five countries across the five continents.

Today, the company continues to expand, in keeping with its global growth strategy. Recently, it celebrated the construction of a new 50,000-square-foot facility in Columbus, Indiana and is in process of constructing a 55,000-square-foot addition to its existing 86,000-square-foot headquarters in Indianapolis.

In this Q&A, Alex T. Mitchell, VP of Operations at Sentry, discusses the various options the company offers in terms of temperature-controlled systems, the importance of end-to-end cold chain, its extensive security measures, and more.

Contract Pharma: What types of temperature-controlled systems does Sentry offer?

Alex T. Mitchell: Sentry offers a variety of highly qualified temperature-controlled shipping solutions, from room temperature controlled down to vapor phase liquid nitrogen. These systems are built to be bulletproof in transit to allow for product SISPQ to be maintained in transit. This can be anything from a Peli Credo Cube to a SkyCell deep frozen palletized shipper and everything in between. Overall, Sentry Logistics strives to provide the least amount of intervention required when shipping high-value temperature-sensitive pharmaceuticals to our clients.

CP: Why is end-to-end cold chain logistics important?

Mitchell: The materials Sentry encounters are generally high in value and extremely temperature sensitive. Both drug developers and CMOs alike, around the world, take significant time and resources to produce these high-value pharmaceutical APIs, drug products, starting materials, and so on. Along with the intrinsic value to drug developers and CMOs, it is crucial for temperature to be maintained such that product SISPQ and chain of custody are without question. If temperature is not maintained during transit, the integrity of these materials may be compromised, which could potentially put the lifecycle of human clinical trials, commercial fulfillment, and additional development of pharmaceutical material, at risk. It is extremely important for drug developers and CMO’s to choose a compliant GxP provider to move materials globally. Choosing a responsive and compliant provider can strengthen the integrity of their supply chain and provide peace of mind.

CP: How do you ensure that pharmaceutical products remain within the required temperature range throughout the supply chain?

Mitchell: Sentry maintains state-of-the-art facilities for GxP handling of temperature-sensitive pharmaceuticals when they are at rest in the US and the EU, with multiple redundancies across refrigeration, power and temperature monitoring.

When Sentry is handling logistics, via our end-to-end offering, the highest quality shipping systems are used. For instance, phase change material and vacuum insulated panels are leveraged for refrigerated movements and these shippers are held at refrigerated conditions while in transit. This stops their validation clock to allow for almost indefinite transit, mitigating the possibility of a temperature excursion. These types of measures ensure that materials’ SISPQ is not affected while in transit or at rest within any of Sentry’s global facilities.

CP: What kind of security does Sentry offer for cold chain logistics?

Mitchell: Sentry provides multi-layered security footprints globally for its GxP sites and ships pharmaceutical materials in over 10 different temperature ranges. These enhanced security measures begin at Sentry’s perimeter fencing and gates when pharmaceutical materials arrive or depart, move through or remain in our temperature-controlled environments, and transition on to their next destination.

When it comes to the movement of materials, globally, in transit we can supply everything from armed follow vehicles to redundant live tracking, geofences for movement of materials, and just-in-time notifications. We supply granularity to event-driven notifications as well. For instance, if a shipper is opened while it is in customs, a notification is received automatically when exposed to light. The sealing, security, and integrity of a client’s materials in transit are of utmost importance. It is Sentry’s number one priority to streamline the process and safeguard these highly temperature-sensitive materials, throughout their lifecycle.

CP: What are the challenges of providing end-to-end pharmaceutical cold-chain logistics?

Mitchell: Much like any logistics arena, there are inherent challenges to moving materials domestically and globally. When it comes to end-to-end pharmaceutical cold chain logistics, there are multiple added components of complexity, especially when maintaining temperature and further chain of custody during transit.

Sentry’s mandate is to ensure no tampering has occurred while materials are moving between states or countries. We find that open dialogue and transparent communication are paramount to drug developers, CMOs, and the owners of these materials. It is crucial to keep our clients apprised of the most up-to-date status of material movements to ensure timely delivery that meets or exceeds expected timelines, and to prevent disruptions. It is also imperative that the appropriate partners are utilized for timely communication and transparency while materials are in transit. By ensuring specific temperature ranges are being maintained and recorded, we further close the loop on the transmission of temperature data and guarantee safe arrival of the product to its final destination.

CP: What technologies does Sentry use to track and monitor the temperature of pharmaceutical products?

Mitchell: Sentry utilizes fully validated 21 CFR Part 11 compliant Building Management System(s) for monitoring and tracking of temperature of those materials while they are in our facilities at rest.

When it comes to movement of materials, a variety of systems are used from Sensitech Temptale Ultras for a GXP temperature trace and Tive loggers for live cellular tracking. Often, multiple loggers are used for redundancy, as an additional layer of risk mitigation.

Sentry uses Tive Live loggers for live logging in transit, allowing for direct client viewing of materials while they are moving globally at temperature. There are a variety of risk mitigating measures we can supply based on potential hazards associated with shipment(s). The extent of tactics deployed is driven by the risks associated with destination, transit time, shipping temperature, how much visibility the client prefers, value of the shipment, etc.
 
CP: What are your contingency plans in case of a power outage or other disruption to the cold chain?

Mitchell: Sentry employs a multiply redundant approach to everything from refrigeration to controls to backup power while at rest. Our headquarters facility in Indianapolis has 200% redundant facility backup power. If we were to have a commercial power failure our systems automatically transfer to one of the generators. If the generator in use needs to be shut down or fails, there is an automatic failover to the second generator.

Electricity is Sentry’s most critical resource to maintain temperature of materials. When in transit, disruption to cold chain is mitigated by Sentry’s preference to use passively driven refrigeration systems. By leveraging passive systems, there are no active refrigeration systems to fail. While failures of actively powered shippers are rare, we see those systems as containing moving parts that are a risk. Highly qualified passive systems that require no intervention and no charging in transit are Sentry’s preference. This allows for any disruption, whether it be a shipment that is rejected from being loaded on an airline or a delay for a consignee to receive the material. Sentry takes an approach of mitigating every risk, while planning and executing our services, whether material is at rest or en route.

CP: How do you work with your clients’ regulatory agencies to ensure compliance with cold-chain requirements?

Mitchell: At Sentry, we work closely with our clients to maintain compliance with the cold-chain requirements of global regulatory agencies, such as the FDA, EMA and PMDA. Our extensive experience working with, and being audited by, these regulatory bodies and our pharmaceutical clientele enable us to provide valuable feedback and consultative services.

Sentry offers a comprehensive range of services, including shipping lane validations and test shipments, to ensure that critical materials are maintained at the appropriate temperatures throughout the supply chain. Our subject matter expertise supports clients in navigating regulatory requirements from preclinical to commercial stages, ensuring rigorous compliance of cold-chain processes not only at rest but in transit. Our approach also guarantees that products are not only stored correctly but safely transported to their destination, ensuring they remain viable for use.

CP: How did the pandemic and COVID-19 vaccines impact the demand for cold chain technologies?

Mitchell: COVID-19 vaccines, while unique in the public eye, utilized well established technology to move materials globally at ultra-low temperature conditions in the mRNA field. These technologies were readily available for pharmaceutical storage and movement of materials in advance of COVID-19 and the development of those vaccines. These vaccines injected an unprecedented increased need for movement of materials at ultra-low temperature conditions, which caused supply chain gaps in availability of appropriate shipping systems. Also, shipping lanes became scarcer due to reduced passenger flights globally. These became pain-points for clients and other service providers when moving critical pharmaceutical materials around the world.

Overall, the impact of COVID-19 drove more development for a variety of different types of systems globally and further capacity across the high-quality providers of systems moving temperature sensitive pharmaceuticals.

CP: What are the latest trends in pharmaceutical cold-chain logistics?

Mitchell: From Sentry’s perspective, the latest trends in pharmaceutical cold chain logistics are often centered around progressive innovation as it pertains to the packaging of highly qualified shipping systems. SkyCell, a Swiss company and leader in the pharmaceutical supply chain, strives to assist pharma companies and service providers, such as Sentry, by producing innovative, secure, and sustainable containers and technological solutions. These actively networked passive containers are built to the highest standards and set the bar for companies to strive for innovation.

Va-Q-tec and Peli are amongst others offering innovative container solutions that mitigate risk when moving pharmaceutical materials globally, in often challenging environments. Shipping system service providers have taken on the mission to provide bulletproof qualification of their systems, to push the boundaries of longest qualified time for movement of materials at temperature, and to provide maximum visibility for these high-value movements. Most everything that Sentry handles is ultra-high value, and our clients entrust us to keep their materials safe. Today, traceability is better than ever, due to active logging systems available on the market, allowing for real-time response(s) to issues in transit. The market is ever-growing and there continue to be opportunities for improvement to leverage cutting-edge solutions for the delivery of temperature sensitive medications.

CP: What are your plans for the future of pharmaceutical cold-chain logistics?

Mitchell: Sentry provides bespoke white glove services and end-to-end movements of ultra-high value materials and storage of materials, globally. Our intention is to evolve this business model by providing appropriate care and redundancies for pharmaceutical materials in transit and at rest to ensure peace of mind. We understand that we are not the owners of these materials and act as guardians when they are not in the owner’s care. Expansion of these custom service offerings across the US, EU and APAC is driven by our clients’ needs. Our mission is to provide services across a variety of geographies while continuing to expand our capabilities, evaluating the newest technologies and remaining steadfast to those that are battle-tested. It is necessary that Sentry maintains a competitive-bleeding-edge approach to cold chain logistics with a zero-loss record across thousands of movements and transactions since our inception in 2006.