IPI Summer 2021

Page 94

Logistics & Supply Chain Management

Lessons Learned from the COVID-19 Vaccine Cold Chain Control Tower Supply chain visibility technology is proving its worth in the distribution of vaccines and has broader applications. Now that COVID-19 vaccines have received regulatory approvals and vaccine manufacturers are producing a steady and increasing supply, the focus has shifted from manufacturing to distributing doses. Vaccine manufacturers have been working closely with cold chain distribution experts and technology providers to plan for monitoring and maintaining the cold chain to ensure the integrity of these crucial products. The vaccines that are currently in distribution must be transported and stored at temperatures ranging from refrigerated (2–8°C) to frozen (-20°C), or in a dry ice environment, with specific requirements, depending on the manufacturer and vaccine composition.

distributing vaccines globally to regions with varying degrees of infrastructure and regulations. Gaining visibility from manufacture through last-mile delivery, and even onsite, has been critical to ensure vaccine integrity and help stakeholders make critical decisions as they are needed. Vaccine Cold Chain Challenges and Successes Aside from the rapid scientific development needed to develop an effective vaccine, manufacturers were tasked with gaining stakeholder engagement and buy-in on a level never previously seen. The urgency created by the pandemic and the rapid distribution required led to a change in the way systems and processes previously have worked. Ensuring regulatory compliance required team collaboration across large organisations, governments, and other external parties.

Many parties from all parts of the distribution chain — from developers of thermal packaging, IoT data loggers, and supply chain visibility data automation software systems, to dry ice and vial suppliers, airlines, and carriers — stepped up to prioritise vaccine distribution and solve one of the greatest logistical challenges we have seen.

In a normal cold chain, pharmaceutical manufacturers must have rapid, accurate, and comprehensive capabilities in place to understand where products are and the condition they are in at all times. There are several risk factors in the cold and ultracold chain of COVID-19 vaccine distribution, and for most vaccines generally. First, vaccines must be stored at low and ultra-low temperatures, some of which must be kept at lower than the usual cold chain standard of 2–8°C. Any deviations in temperature during transport or storage can make the vaccine ineffective or even unsafe. Additionally, delays and losses of product in the supply chain can lead to critical vaccine shortages in areas that have been severely affected by the pandemic.

Over the last several months, we have seen tremendous efforts across the COVID-19 vaccine distribution channel, with parties coming together to help solve a common goal for humanity. While we learned during the H1N1 outbreak more than one decade ago that digitally connecting and transforming the end-to-end would be paramount for future supply chains, this guiding principle has proven essential during the current pandemic.

There are handoff points along the supply chain, and each one poses risks of temperature deviations, like pallets being split up or other incidents that can compromise the products' quality condition. Likewise, the receiving facility staff, including hospitals, clinics, and pharmacies, must review and understand all handling and storage instructions as well as the vaccine quality and safety conditions for each vaccine.

With a significant global impact and human health at stake, manufacturers were tasked with rapid vaccine development, and

Some of the COVID-19 vaccines are shipping directly from the manufacturing site to receiving sites using a high-speed

Pfizer and BioNTech's COVID-19 vaccine was authorised with stringent requirements of the currently authorised products, with storage between -80 °C and -60 °C. The vaccine is being shipped in thermal containers designed to hold dry ice for both shipping and temporary storage.

92 INTERNATIONAL PHARMACEUTICAL INDUSTRY

delivery model. This typically has involved air and road freight directly to receiving sites. To ensure the successful and rapid delivery of these sensitive products, shipping in high-volume, small parcel increments, realtime, actionable communication among stakeholders was needed. This requires connecting technology systems and activities to align people and processes and ensure vaccine integrity. Many supply chains have traditionally used passive and limited use IoT data logger technologies that provide descriptive data, showing what happened after the fact. This delay in information is problematic because stakeholders cannot act on the data to prevent waste and loss. Vaccine integrity has never been more crucial as millions of COVID-19 treatments have already shipped, and potentially more than one billion will ship over the next 12–24 months. Real-time, GSM-enabled IoT data logger technology and cloud-enabled analytics were designed to measure various scenarios that would require escalation in addition to temperature deviations and geolocation, which can detect if shipments are delayed, or products are split up or arrive at a wrong location. This technology is needed to support the rapid deployment of vaccine distribution on a global scale. Additionally, 24/7 monitoring and response services were required to respond to escalations and work with relevant parties to prevent vaccine product loss. From a technology viewpoint, connecting people, processes, and stakeholders, both internally for manufacturers, and externally among its selected suppliers, carriers, and other stakeholders, has required a comprehensive mapping of new workflows and then building data and automation models to help streamline their efficiencies. For example, by integrating an enterprise resource planning (ERP) system with a real-time supply chain visibility software platform, carriers' own internal supply chain control tower system, and a quality management system, has connected and streamlined many value chain activities, spanning business, manufacturing, quality, and logistics. Summer 2021 Volume 13 Issue 2


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Articles inside

Pharma Airports: A Key to Global Success?

15min
pages 102-108

Lessons Learned from the COVID-19 Vaccine Cold Chain Control Tower

10min
pages 94-99

The role of Hostile Vehicle Management in a Protective Security Strategy

7min
pages 100-101

Trust But Verify: Importance of Packaging Compendial Testing to Secure the Parenteral Drug Supply Chain

19min
pages 88-93

Tackling Supplier Management Challenges to Build a More Agile and Resilient Supply Chain

6min
pages 84-85

EU Falsified Medicines Directive

8min
pages 76-80

Covid Vaccination Serialisation – The Journey So Far

8min
pages 86-87

Thinking Inside the Box

10min
pages 81-83

Fake Medications? Suggestions and Approaches to Help Ensure that Patients and their Family Members are Not Left Worrying

5min
pages 74-75

Serialisation: Headache or Opportunity?

10min
pages 70-73

How the Rise of Biologics is Spurring a Packaging Revolution

6min
pages 68-69

Extrusion-Moulding-Coating Process Advantages for Continuous Manufacturing of Oral Solid Dosage Forms

12min
pages 62-67

Pharmaceutical Trends: Water Activity Measurement

12min
pages 54-57

Dwell Time and its Influence on Tablet Production

8min
pages 58-61

Medical Monitor’s Conundrum: Making Sense of Site/Central Discordance in Radiology Assessment

11min
pages 50-53

Choosing the ‘Right’ Device to Deliver Your New Therapy Four Simple Steps

10min
pages 46-49

How Endotoxin Contamination Can Affect Gene and Cell Therapies

10min
pages 42-45

Accelerating Pharma Research with Sensitive Spatial Analysis of Challenging Molecules

11min
pages 36-41

Time to Put the Spotlight on the Substance of your Drugs through Solid-form Development

10min
pages 32-35

Compartmentalised Microfluidic Devices for Drug Discovery

11min
pages 28-31

How Technology can Help Build a Fairer, Healthier World

19min
pages 12-17

Digital Technology for Building Resilient Healthcare Systems in Thailand and Southeast Asia

8min
pages 22-23

A World Leader in Naturally Derived Products Discusses Commercial Success and New Innovations

6min
pages 10-11

Editor’s Letter

5min
pages 8-9

The EU Medical Devices Regulation and its Market Impact Under the Spotlight

10min
pages 18-21

Multifactorial Disease Models: Their Role in De-risking Topical Formulation Development (MedPharma)

13min
pages 24-27
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