Temperature-controlled packaging plays a crucial role in the biopharma industry, ensuring the safety, efficacy and quality of temperature-sensitive products such as vaccines, biologics and specialty medications.
With biologics now representing over 40% of all pharmaceutical products in development, maintaining precise temperature control throughout the supply chain has become more important than ever.
The temperature controlled pharmaceutical packaging solutions market has been estimated to be worth USD $4.8 billion in 2024, and it is predicted to reach a global market valuation of USD $7.7 billion by 2034, growing at a CAGR of 4.8% from 2024 to 2034. (Source)
This guide, in association with Intelsius, explains the importance of temperature-controlled packaging, key trends to how to be successful.
Temperature-Controlled Packaging defined
Temperature-controlled packaging refers to specialised packaging solutions designed to maintain a consistent temperature for sensitive products during transportation and storage. This type of packaging is crucial for goods that are temperature-sensitive, such as pharmaceuticals, vaccines, biologics, perishable foods and chemicals.
It includes insulated containers, refrigerated units and advanced materials like phase-change materials (PCMs) and vacuum-insulated panels (VIPs) that ensure temperature stability over varying durations and environmental conditions.
Proper temperature control is essential to maintain the stability, safety and effectiveness of pharmaceutical products.
In biopharmaceuticals such as vaccines, insulin, monoclonal antibodies and cell-based therapies, small temperature excursions can cause degradation and loss of biological activity, rendering treatments ineffective or even hazardous. If too cold, proteins can become denatured or crystallised, rendering the product ineffective or harmful. If too warm, the product can become degraded, causing chemical reactions such as hydrolysis or oxidation, leading to loss of biological activity.
Proper temperature control is, therefore, a cornerstone of biopharmaceutical handling, ensuring these life-saving products are both effective and safe when delivered to patients.
Common Temperature Ranges for Biologics
| Storage Condition | Temperature Range | Example Products |
| Controlled room temperature | 15°C to 25°C | Some protein products |
| Cold chain | 2°C to 8°C | Monoclonal antibodies, insulin, most vaccines |
| Frozen | -25°C to -15°C | Some vaccines, enzyme products |
| Deep frozen | -70°C to -50°C | mRNA vaccines, certain cell therapies |
| Ultra-cold chain | -196°C | Cell and gene therapies |
Regulatory Compliance
As well as ensuring the efficacy and safety of biopharmaceutical products, temperature-controlled packaging ensures compliance with regulatory agencies, such as the FDA, EMA and WHO, which have strict guidelines on the storage and transport conditions for biopharmaceuticals.
Deviations can result in product recalls, fines or loss of approval to market the product. In 2019 the IQVIA Institute estimated that the pharmaceutical industry loses roughly $35 billion annually because of failures in temperature-controlled logistics.
Proper temperature monitoring and documentation are required to demonstrate compliance with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
Properly deploying temperature-controlled packaging solutions and a clear understanding of how to meet regulatory standards will ultimately impact patient outcomes. Failure to do so could lead to temperature fluctuations and the formation of harmful byproducts or contaminants. For instance, improperly stored vaccines may lose their protective effect, exposing patients to preventable diseases.
In some cases, temperature abuse can cause visible changes (e.g., cloudiness, precipitation) or subtle changes that are not immediately noticeable but can still pose risks.
Key Trends in Temperature-Controlled Packaging
The temperature-controlled packaging industry is evolving rapidly to meet the demands of sectors like pharmaceuticals, biotechnology, food and e-commerce.
Some key trends emerging from the sector include:
Sustainability
Increasing focus on eco-friendly materials like recyclable, biodegradable or reusable packaging to reduce environmental impact.
For example, Intelsius have recently launched GreenTherm, the 100% recyclable temperature-controlled packaging system. These solutions offer multi-use products and rental services, giving customers truly circular solutions to their cold chain shipping needs.
GreenTherm is a fully recyclable temperature-controlled packaging by Intelsius
Advanced Insulation Technologies
Use of phase change materials (PCMs), vacuum insulation panels (VIPs) and nanotechnology to improve thermal performance and extend temperature stability.
VIP insulation performs significantly better than foam insulations when it comes to temperature loss. For example, a system built using Expanded Polystyrene could require up to five times the thickness of insulation compared to VIP, meaning that the use of VIP can significantly reduce the overall size of a packaging system.
The below graph illustrates how VIP insulation performs vs EPS when comparing both materials when using dry ice as a coolant.
Intelsius’ ORCA range utilises both PCM and VIP technology to achieve high-performance temperature control against challenging ISTA 7D Winter and Summer profiles, ensuring biopharmaceutical products can travel safely and compliantly through even the most extreme weather conditions.
Digital Integration
Incorporation of IoT-enabled sensors and real-time tracking to monitor temperature, humidity and location for improved supply chain transparency. Products such as ORCA Connect Vision allow for live data monitoring anywhere in the supply chain. Key data can be tracked either at the logger window itself or remotely using ORCA Cloud, their cloud-based data monitoring platform, accessible anywhere in the world.
ORCA Connect Vision allows for live data monitoring anywhere in the supply chain using a data logger (pictured below).
Types of Temperature-Controlled Packaging and Best Practices
Before transporting any temperature-sensitive products, it is important to understand the temperature requirements of the payload, the distances and time it will travel, and the conditions through which it will travel, as all these elements will impact what type of temperature-controlled solution one chooses.
There are many different elements to temperature-controlled packaging, all of which will require consideration before choosing the right solution.
Some key considerations are:
Active or Passive: There are two major ways to move temperature-controlled products or payloads: passive provision or active provision of temperature control.
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- Active systems are what one typically thinks of as temperature control; freezers, fridges and cold rooms. When it comes to shipments, these active systems are typically mounted on trailers, vans or pallets. They provide thermal control which actively responds to the adverse temperatures outside.
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- Passive systems are less obvious and most people would know them from coolers or chilly bins, combining ice or cool-packs with insulation to provide a fixed amount of thermal protection. Their ability to protect a payload depends upon the design and preparation of the passive system.
Payload Volume: Depending on what temperature-sensitive cargo is being shipped, and the volume it is being shipped in, one may be able to use one small temperature-controlled solution. However, if transporting bulk quantities of pharmaceutical products, larger, pallet-sized or even multiple solutions may be required.
Duration: Duration relates to the number of hours a temperature-controlled solution will keep products at the correct temperature. Depending on the distance of sending the payload, the external thermal environment and the shipping choices made (road, sea, air, etc.), one needs to select a solution that will maintain the desired temperature range for as long as needed.
Temperature Range: Before purchasing temperature-controlled packaging, one should understand the temperature range the payload requires to retain efficacy. Whether it is -70°C or 2°C – 8°C, the solution will need to come with the correct phase change material.
Single or Multi Use: Depending on what is being shipped, and how many times it needs to be shipped will influence whether a single-use or multi-use solution is required. Intelsius provides both single-use and multi-use solutions as part of their ORCA range and would suggest investing in a multiple-use system when shipping specific payloads more than once, or between multiple locations.
Payload Visibility: Payload visibility ensures real-time tracking and monitoring of the product’s condition. Intelsius offers connected temperature-controlled packaging solutions with onboard data logger capabilities and cloud-based data tracking technology, allowing tracking of internal and external temperatures and GPS location. For extra oversight of payload in transit, they recommend connected solutions such as their ORCA Connect system.
Pre-Conditioning: Pre-conditioning in temperature-controlled packaging is a crucial step, especially for passive systems that use phase change materials (PCMs).
Intelsius can pre-condition the majority of their temperature-controlled packaging solutions to meet specific needs. If solutions are required to arrive ready for payload addition, this should be requested upon purchase. If pre-conditioning is not chosen, the box and PCMs will need to be conditioned to the desired temperature range.
Temperature-controlled packaging represents a critical component in the pharmaceutical cold chain, as biologic products continue to dominate pharmaceutical development pipelines. Success in this area requires careful consideration of packaging selection, regulatory compliance, and emerging technologies, while maintaining focus on sustainability and cost-effectiveness.
CASE STUDY
Temperature-Critical Logistics: A2 Cargo’s Success Story with Intelsius
A2 Cargo, one of Lithuania’s pioneering freight forwarders, has achieved remarkable success in temperature-critical shipping through its partnership with Intelsius, a leading manufacturer of temperature-controlled packaging solutions. The collaboration has resulted in zero temperature excursions across over 9,600 shipments in 2022, maintaining critical quality standards for pharmaceutical and clinical trial deliveries.
Company Background
Founded in 1994, A2 Cargo has evolved from an air freight specialist to a comprehensive logistics provider across the Baltic region. Operating from five sites with over 60 employees, the company serves eight of the world’s top ten pharmaceutical companies, focusing on manufacturers, wholesalers, central labs, clinical research, and biotech clients.
The Challenge
A2 Cargo faced several critical requirements in their temperature-controlled logistics:
- Maintaining precise temperature control throughout complex supply chains
- Meeting strict 48-hour delivery windows
- Finding cost-effective solutions considering air freight weight restrictions
- Ensuring GDP compliance and proper validation documentation
Partnership Solution
In April 2019, A2 Cargo partnered with Intelsius, implementing their packaging solutions across multiple temperature ranges (2-8°C, 15-25°C, -20°C, and dry ice).
Key advantages of the partnership included:
- Extended validation time of 96 hours, double the standard requirement
- Lightweight packaging design reducing air freight costs
- Single-use shippers eliminating packaging loss and damage concerns
- Comprehensive technical support and custom configuration options
Results and Impact
The partnership delivered exceptional results:
- Zero temperature deviations across 9,600+ temperature-sensitive shipments in 2022
- 99.8% quality target achievement
- No claims or temperature-related issues
- Improved patient outcomes through consistent, reliable medical product delivery
Future Outlook
A2 Cargo anticipates significant growth in temperature-controlled shipping volumes, with expectations to nearly double their current operations. The partnership with Intelsius continues to provide a foundation for scaling their temperature-critical logistics services while maintaining their exceptional quality standards.
This successful collaboration demonstrates how strategic partnerships in the pharmaceutical logistics sector can deliver crucial improvements in supply chain reliability, ultimately benefiting both healthcare providers and patients.
Intelsius have been designing and manufacturing intelligent sample transport and temperature-controlled packaging solutions for over 20 years. With both a significant range of off-the-shelf Category A and B compliant solutions and bespoke packaging solutions available, they ensure you can safely and compliantly ship your temperature-sensitive products and human samples anywhere in the world.
For more information about how Intelsius can help you connect your cold chain and achieve your sustainability goals visit their website
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