Warum die Pharma-Kühlkette eine Ultra-Tieftemperaturverfolgung und hochpräzise Zustandsüberwachung benötigt

So far, this has been a decade of unprecedented uncertainty and rampant chaos in all global supply chains, none more than the cold pharma chain. The dawn of 2020 brought pandemic-driven disruptions, including border lockdowns, quarantines, and labor shortages that exacerbated logistics and distribution challenges already rife with human error and operational inefficiencies. While the weight (and wait) of the world fell on supply chain leaders’ shoulders as delays became commonplace, the cold, hard truth is that the impact was particularly hard on those waiting on the research, development, and distribution of temperature-sensitive pharmaceutical and medical products.

Pharma cold chain logistics requires strict adherence to temperature ranges, regulatory controls, and tight expiration windows. When dealing with products that require ultra-low temperature tracking and monitoring — vaccines, biosamples, blood, and cell and gene therapies (CGT)  are just a few examples — even the slightest temp excursion, failure to comply, or shortest delay could result in a lost shipment worth millions. In fact, failures in the pharma cold chain alone cost the industry an estimated $35 billion annually.

There is, however, a silver lining in this cloud that has been hanging over pharmaceutical supply chains in recent years. Many pharma companies now realize that end-to-end visibility is a must-have to monitor drugs and therapeutics at every step of the cold chain journey, from development and manufacturer to patient. Without the insights afforded by end-to-end visibility, manufacturers, shippers, and their pharma cold chain partners will be hindered by poor planning, inaccurate predictions, and delayed decision-making. As a result, they’ll face increased risk, which leads to more waste, which increases costs and could put lives at risk.

This article explores the growing need for ultra-low temperature tracking and hyper-accurate condition monitoring in the pharma cold chain and how to get that level of insight. Specifically, we will address the following:

1. The State of the Pharmaceutical Cold Chain
2. A Complex Ecosystem Begging for Visibility Support
3. Pharma Execs: Here is What to Look for in a Visibility Solution
4. The Benefits of Real-Time Visibility in the Pharma Cold Chain
5. Trust Tive to Gain Complete End-to-End Cold Chain Pharma Visibility

I. The State of the Pharmaceutical Cold Chain

As the global pharma cold chain market continues to expand, so does the demand for real-time temperature tracking. Worldwide sales of cold chain drugs and biologics will likely top $440 billion by 2024, with the overall biopharma market exceeding $1.58 trillion. According to the MarketsandMarkets research, the cold chain monitoring market is expected to reach $10.2 billion by 2026, up from $4.7 billion in 2021.

Maintaining product integrity is becoming increasingly challenging amid this unprecedented growth. Many cold chain pharmaceutical products must be stored and transported in temperature-controlled environments ranging from minus-50℃ to minus-200℃ and have a lower tolerance for excursions. GPS devices can be an invaluable resource for tracking these shipments.

Pharmaceutical cold chain management often involves multiple 3PLs and other partners, including packaging experts. The number of handlers expands as the market becomes increasingly global, which increases the risk of damage, spoilage, and product loss due to theft. When factoring in those challenges with the usual disruptions found in any global supply chain—labor, driver and capacity shortages, geopolitical conflicts, port congestion, and more—it’s easy to see why delays happen. Without end-to-end shipment visibility and real-time tracking capabilities, risk and uncertainties in the cold pharma chain can translate into incredible waste.

The Focus on Reducing Waste

A primary goal of temperature tracking and condition monitoring is to reduce waste in the pharma cold chain. The pandemic brought this to the forefront because the vaccines developed at warp speed to fight the spread of COVID required strict temperature control: Pfizer-BioNTech (minus-80℃ to minus-60℃), Moderna (minus-25℃ to minus-15℃) and Johnson & Johnson (2℃ to 8℃). Maintaining strict adherence was quite challenging, as these startling statistics indicate:

• Quality control issues led Emergent BioSolutions to discard or destroy up to 400 million doses’ worth of an essential ingredient found in Johnson & Johnson’s and AstraZeneca’s coronavirus vaccine between March 2020 and February 2022.  
• The Centers for Disease Control and Prevention estimates that 15 million doses of COVID vaccine in the U.S. were wasted in a six-month period alone in 2021.
• According to the World Health Organization, up to 50% of global vaccines are wasted annually. Furthermore, the world could waste a billion or more COVID vaccines a year at that rate.

A single anomaly can ruin entire batches of cold chain pharmaceutical products, such as blood used for transfusions, patient-specific biosamples needed for cancer research, and biotechnology products such as vaccines. Some shipments of vaccines can cost between $500,000 and $1 million. Cell therapies typically cost about $500,000 per treatment; gene therapies can easily approach $1 million per treatment course.

Visibility and real-time alerts allow stakeholders the opportunity to mitigate excursions that save shipments and prevent waste with any cold pharma shipment that requires ultra-low temperatures.

A Highly Regulated & Secure Arena

Pharmaceutical cold chain management involves teams dedicated to ensuring medicines and advanced treatments adhere to all applicable legislation—laws enacted at the government level—and regulations, which are rules passed by agencies that interpret the laws to facilitate their practical implementation. Nearly all governments worldwide have agencies whose regulations aim to ensure product quality, safety, and efficacy of all drugs and treatments. Examples include:

• United States – Food and Drug Administration (FDA)
• European Union –  European Medicines Agency (EMA)
• Australia – Therapeutic Goods Administration (TGA)
• United Kingdom – Medicines and Healthcare products Regulatory Agency (MHRA)
• South Africa – Medicines Control Council (MCC)

Compliance also applies to the technologies and equipment used to monitor temperature-sensitive products while in storage or in transit. Regulatory agencies won’t simply accept assurances that the tracking tools measured accurately and that cold chain custody was indeed uninterrupted. They’re going to want documented validation. For example:

• FDA 21 CFR Part 11 and EU Annex 11 compliance ensures that electronic records associated with cold chain pharmaceutical products can be trusted in the same way as handwritten records.
• A 3-Point NISTtraceable Certificate of Calibration provides evidence that the trackers and probes (either dry ice or cryogenic) used to monitor ultra-low temperatures have been calibrated by an ISO 17025-accredited laboratory. 
• GxP compliance demonstrates that a pharma company follows the guidelines of Good Manufacturing Practices (GMP) and that all components used in tracking and monitoring its cold chain products were developed and tested following the Good Automated Manufacturing Practice 5 (GAMP 5) model.

Raising the Stakes on Temperature & Time

Technology and real-time visibility have always been a top priority in the pharma cold chain and other industries requiring constant monitoring of location, temperature, and conditions.

Read our white paper:

How to Implement Real-Time Tracking of Valuable Perishable Shipments

However, with the onset of COVID came an unprecedented awareness among industry professionals and the general public that tracking and monitoring temperature-sensitive products play a critical role in ensuring they get delivered on time, in full, secured and safe. As the virus quickly reached pandemic status and indiscriminately swept across the globe, there was immense pressure to develop and commercialize a COVID-19 vaccine as death tolls surpassed millions. In addition, the ongoing demand for seasonal flu vaccines and the need to move forward with many cell and gene temperature-sensitive therapies meant professionals had to juggle priorities like never before.

The cold chain management of pharmaceutical products required supply chain professionals to innovate to meet increasingly stringent storage and transportation requirements for the COVID vaccines and other high-value products.

It was no longer acceptable to simply know a shipment’s precise location. Stakeholders also needed to track real-time temperatures, humidity levels, and more to gain maximum transparency into global shipments from anywhere in the world. With the latest tracking technologies and cloud-based platforms, cold chain pharma professionals could capture data at the SKU or package level as well as at the container level.  

This data, supported with configurable real-time alerts, provides actionable information stakeholders can use to identify and mitigate temperature excursions and other deviations, thereby saving pharma shipments. It also helped cold chain logistics partners optimize routes to reduce the risk of potential delays.

II. A Complex Ecosystem Begging for Visibility Support

Even as COVID continues to subside, emerging into a new reality demands that pharma cold chain practitioners leverage the lessons learned over the past few years and continue to invest in tracking technologies and visibility solutions. Pharmaceutical shipments such as vaccines, CGTs, and immunotherapies typically involve multiple supply chain partners working in close collaboration to execute a number of handoffs from the time a product leaves a manufacturing plant until it reaches its ultimate destination. In most cases, that means a hospital, clinic, or pharmacy, though home deliveries are now commonplace for some diabetic or cancer medications.

Choosing the best transportation mode(s) is only the beginning. Relying solely on shipping express by air directly from the manufacturer to the point of care might not be the best choice because it is often cost-prohibitive. Ocean transportation is far cheaper than shipping via air, but it takes much longer. Moving cold pharma products via trucks also presents challenges such as driver shortages and limited capacity. A combination of these modes might be the best solution, provided all partners work together to optimize the pharmaceutical supply chain from end to end, limiting the number of handoffs and time spent out of refrigerated or frozen environments. Maintaining and documenting cold chain custody from the point of origin to final delivery is the ultimate goal; state-of-the-art temperature trackers, cloud-based platforms, and real-time alerts are needed to achieve unbroken cold chain custody at every stage of the segmented journey.

Pharma Cold Chains Need Real-Time Visibility & Live Location/Condition Monitoring

So many things are beyond a manufacturer’s or shipper’s control once a cold pharma shipment leaves a tightly monitored, temperature-controlled environment of a manufacturing facility, hospital, or clinic. A lack of true visibility across the entire supply chain from development to patient leaves stakeholders unable to plan properly, predict accurately, or make critical data-backed decisions at a moment’s notice to correct temperature excursions and mitigate disruptions.  

Tive, a leading provider of real-time visibility and tracking solutions, understands the challenges of cold chain logistics. With the help of polygon geofencing, Tive helps supply chain professionals actively monitor the in-transit location and temperature of pharmaceutical and biological shipments. This approach reduces the risk of excursions and helps assure product quality from the point of origin to the final destination.

III. Pharma Execs: Here is What to Look for in a Visibility Solution

Pharmaceutical, biotech, and pharma logistics companies need a complete cold pharma chain visibility solution that must ensure the successful delivery of products by reducing excursions and assuring product quality to minimize spoilage, waste, theft, and delays. Passive data loggers don’t provide the necessary visibility—and don’t make it possible to take immediate action when excursions happen.

Tive is revolutionizing how pharmaceutical and biological shipments are monitored by providing validated, real-time visibility into shipment location and temperature — from point of origin to the point of use. In addition, Tive’s solution supports the full temperature range of your cold chain, is GxP-compliant, and follows the guidelines of Good Manufacturing Practices (GMP).

True Visibility

Tive provides real-time visibility from the moment a Solo 5G tracker is placed and activated on a shipment, pallet, or container. Its trackers, cloud-based application, and real-time alerts help eliminate temperature excursions and assure product integrity of every shipment from the point of origin to the point of use.

Hyper-Accurate Location & Conditions Details In-Transit

Tive Solo 5G hyper-accurate, multi-sensor trackers capture and transmit real-time shipment location and temperature data. Unlike competitors’ passive data loggers that require downloading the data, the data Tive collects is accessible in the cloud 24/7/365 from anywhere in the world.

Tive in Action:

Read How Tive’s Tracker Kept a Surgery on Schedule

Actionable Information to Manage By Exception

You need actionable information to plan ahead or take timely actions that help your shipments arrive on time and in full (OTIF). The Tive application delivers actionable, real-time data associated with each in-transit shipment. This cloud-based technology helps reduce or eliminate preventable theft, product damage, and delays.

Tive in Action:

Driving Proactive Pharma Logistics

Item-Level Tracking

A Solo 5G tracker attached to each pharma shipment provides shippers and stakeholders with valuable, actionable information and a level of supply chain serialization required by the EU’s Falsified Medicines Directive and the FDA’s Drug Supply Chain Security Act. Highlights of item-level tracking include:

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• Visualization and monitoring – Location, temperature, humidity, and security.
• Shipment analysis – Storecards and reports on different modes and lanes enable you to assess performance.
• Real-time actionable alerts – Allow for planning and response.
• Cloud-based records – Dokumentierter Nachweis der Einhaltung der FDA-Richtlinien.
• Lithiumfreie Sensorbatterien – Sicherheit und Nachhaltigkeit.
• Einweg – Eliminiert Herausforderungen bei der Rückwärtslogistik.
• Globale Mobilfunkabdeckung – LTE IoT Cat-M1 (4G/5G), GSM (2G) Fallback gewährleisten eine kontinuierliche Sendungsverfolgung.
• 24/7-Überwachung verfügbar – Erweitert Ihr Team um Logistikexperten von Tive.

Tive in Aktion:

Wie Echtzeit-Transparenz Sendungen rettet

Verfügbarkeit von Kryo- und Trockeneissonden

Die meisten Produkte, die in der Pharma-Kühlkette transportiert werden, erfordern die Verfolgung und Einhaltung extrem niedriger Temperaturen. Tive löst dieses Problem mit Trockeneis- und Kryosonden, die 3-Punkt-NIST-kalibriert sind und in Verbindung mit Solo 5G-Trackern arbeiten.

• Die Trockeneissonde ist für Sendungen geeignet, die einen Temperaturbereich zwischen minus 100 °C und minus 50 °C einhalten müssen. Beispiele hierfür sind COVID-Impfstoffe (minus 70 °C), klinische Studien, Spezialpharmazeutika und CGTs.
• Die Kryosonde ist die beste Wahl für Sendungen, die eine noch niedrigere Temperaturkontrolle erfordern, von minus 200 °C bis minus 50 °C. Kryosonden überwachen die Produktstabilität in Kryo-Shippern – Kammern, in denen flüssiger Stickstoff die Sendung umgibt, um sie extrem kalt zu halten. Typische pharmazeutische Anwendungen umfassen klinische Studien, Spezialpharmazeutika und CGTs.

Tive in Aktion:

Lesen Sie, wie Echtzeit-Tracking alle Anforderungen in der Zell- und Gentherapie erfüllt

Tive unterstützt die Einhaltung pharmazeutischer Vorschriften

Eine umfassende Tive-Lösung für die pharmazeutische Kühlkette hilft Ihnen, die strengen Richtlinien der Aufsichtsbehörden einzuhalten. Hier sind drei Schwerpunkte.

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• FDA 21 CFR Part 11. Die Verordnung soll sicherstellen, dass „elektronische Aufzeichnungen“ wie handschriftliche Aufzeichnungen vertrauenswürdig sind.
• Temperaturgenauigkeit und Kalibrierung. Tive Solo 5G Pharma-Tracker wurden von einem ISO 17025-zertifizierten Labor getestet und verfügen über eine 3-Punkt-NIST-Kalibrierung.
• GxP-konform. Unsere Lösung folgt dem GAMP5-Modell – Tive ist stolz darauf, die Good Manufacturing Practices (GMP) einzuhalten, einschließlich GAMP-5. Unsere fortlaufende unternehmensweite Qualitätspolitik und Methodik stellen sicher, dass wir sowohl Hardware- als auch Softwareentwicklungsprozesse dokumentieren und die Ergebnisse sowie Kontrolländerungen validieren.

IV. Die Vorteile der Echtzeit-Transparenz in der pharmazeutischen Kühlkette

Die Tive-Lösung bietet validierte Echtzeit-Transparenz über den Standort und 3-Punkt-NIST-rückverfolgbare Temperaturdaten, um globale pharmazeutische und biologische Sendungen während des Transports aktiv zu überwachen. Die Hauptvorteile sind:

• Nahtloser Zugriff auf genaue Echtzeit-Positions- und Temperaturdaten. Sendungen in Echtzeit aktiv überwachen, um Temperaturschwankungen zu mindern und die Produktqualität zu gewährleisten.
• Den gesamten Temperaturbereich abdecken, um die Anforderungen der Kühlkette zu erfüllen – einschließlich Trockeneis- und Kryo-Sendungen – alles von einem Unternehmen
• Echtzeit-Warnmeldungen erhalten, auf die reagiert werden kann. Handeln Sie bei Abweichungen – reduzieren Sie Produktverschwendung und minimieren Sie die Untersuchung von Abweichungen.
• Bidirektionale Konnektivität. Tracker bei Bedarf während des Transports neu konfigurieren.
• Bereiche zur Verbesserung der Lieferkette identifizieren. Verwertbare Erkenntnisse aus aggregierten Versanddaten nutzen.

Mehr dazu finden Sie in unserer Infografik:

Die Vorteile der Echtzeit-Standort- und Zustandsverfolgung von Pharmasendungen

Vertrauen Sie Tive, um vollständige End-to-End-Sichtbarkeit in der Pharma-Kühlkette zu erhalten

Bei Pharmasendungen in der Kühlkette beginnt der Erfolg mit Sichtbarkeit, Umsetzbarkeit und Verantwortlichkeit. Eine umfassende Transparenzlösung von Tive liefert die notwendigen umsetzbaren Erkenntnisse, um ein effektives Management der pharmazeutischen Kühlkette von Medikamenten, Behandlungen, fortschrittlichen Therapien und anderen biologischen Sendungen zu ermöglichen.

Die hochpräzisen Multisensor-Solo-5G-Tracker von Tive, erhältlich mit Lithium- und Nicht-Lithium-Batterien, gepaart mit einer robusten Cloud-basierten Anwendung, bilden eine Komplettlösung, die alle Beteiligten über den Temperatur- und Zustandsstatus einer Ultra-Kühlversandlieferung informiert. Darüber hinaus ist der Solo 5G Tracker für den einmaligen Gebrauch oder zur Wiederverwendung konzipiert, um Nachhaltigkeitsinitiativen zu unterstützen. In jedem Fall ist er eine hervorragende Lösung, die Temperaturabweichungen und Verzögerungen bei Pharmasendungen in der Kühlkette reduziert.

Sind Sie bereit für ein tiefergehendes Gespräch darüber, wie Tive Pharmasendungen in der Kühlkette schützen kann, die eine Ultra-Tieftemperaturverfolgung und Zustandsüberwachung erfordern? Kontaktieren Sie uns heute.