December 7, 2023

Advanced cold chain solutions for the development of vaccines

In vaccine manufacturing, maintaining precise temperature control throughout the cold chain remains an absolute necessity. The efficacy and safety of vaccines hinge on this critical factor. Even with advancements in vaccine technology, the integrity of the cold chain remains non-negotiable.

In this article, we will discuss the role of temperature control and the significance of an unbroken cold chain in vaccine production and distribution. We will explore the complexities of ultra-cold chains as well as innovative solutions to optimize temperature control in vaccine development.

What vaccines have special cold chain requirements?

Several vaccines demand meticulous temperature control due to their inherent properties and composition. These requirements stem from various factors, including the vaccine's formulation, stability, and susceptibility to temperature variations.

Vaccines targeting diseases like measles, mumps, and rubella are typically stable when stored between 2°C to 8°C. However, large-molecule vaccines, such as novel mRNA vaccines, are more sensitive and necessitate ultra-cold storage below -15°C or even -70°C.

Read more: mRNA vaccines: How to safely ship and store them | Trends in vaccine development

Cold chain requirements of vaccines

The intricacies of ultra-cold chains in vaccine manufacturing

Ultra-cold chains form the backbone of preserving vaccines that demand stringent temperature control. While small-molecule vaccines are usually less temperature-sensitive, the respective cold chains when dealing with large-molecule products operate within extreme temperature ranges, often dipping as low as -70°C or even beyond. Vaccines sensitive to temperature fluctuations, such as those targeting Ebola, certain COVID-19 vaccines, and potential mRNA-based vaccines, necessitate such ultra-cold storage to maintain their efficacy.

The challenge lies not only in achieving these low temperatures but also in sustaining them throughout the entire storage and distribution process. The logistics become intricate as maintaining ultra-cold temperatures demands specialized equipment and robust infrastructure at every stage.

Failure to uphold these stringent conditions can result in compromised vaccine efficacy, rendering the immunization efforts futile. Vaccines, particularly those sensitive to temperature variations, can lose their potency when exposed to inadequate or fluctuating temperatures. This degradation impacts the vaccine's ability to confer immunity, leading to potential health risks and reduced effectiveness in preventing diseases.

Furthermore, mishandling these delicate vaccines can result in significant financial losses for manufacturers, wastage of valuable resources, and erode public trust in vaccination programs.

Hit the right temperature?

Ensuring vaccines reach and maintain precise freezing temperatures is pivotal in preserving their efficacy and safety. Uneven freezing rates pose a substantial risk to vaccine integrity. When vaccines are exposed to uncontrolled freezing, varying ice crystal formations may develop within the formulation. Uncontrolled formation of ice crystals leads to cryoconcentration of API in the center of primary packaging, causing stress to the product.

These irregularities could potentially alter the vaccine's composition and compromise its effectiveness upon administration. Achieving uniform and controlled freezing rates is therefore crucial to maintain the intended characteristics of the vaccine, ensuring it remains potent and ready for distribution.

It is not only vital to achieve the right set of temperature, but also to keep it consistent throughout the vaccine cold chain. Any fluctuations or deviations from the required temperature range can cause irreversible damage to vaccine potency. Temperature excursions, even for short periods, compromise the efficacy of vaccines, rendering them ineffective or less potent.

This challenge intensifies during transportation and storage, where maintaining precise temperatures becomes a critical factor. A minor shift in temperature during transit or storage can result in compromised vaccines, leading to financial losses and undermining vaccination programs' success.

Limiting manual processes in vaccine manufacturing

Manual processes in vaccine manufacturing pose significant risks, primarily concerning accuracy and consistency. Human involvement introduces the potential for errors at various stages, from handling to measuring and mixing critical components prior to freezing. Inconsistencies in measuring or mixing can impact vaccine quality, bat-to-bag consistency, and overall effectiveness.

Moreover, manual handling increases the likelihood of contamination, compromising the sterility of the vaccines. The labor-intensive nature of manual processes also slows down production, potentially impacting supply and distribution timelines. These risks highlight the need for automated and controlled systems to ensure precise and reliable vaccine manufacturing.

Read more: Reducing human errors and technology failures in biopharma

Maintaining the vaccine cold chain – advanced solutions with single-use technologies

Maintaining the vaccine cold chain demands advanced solutions that guarantee temperature control and integrity. Single-use technologies offer innovative approaches to safeguarding vaccine quality.

Bioprocess containers designed for extreme temperatures assure stability, while single-use bag protection enhances handling and safety. Plate freezing, with its controlled freezing rates, optimizes the process, ensuring uniform and reliable results. Moreover, ultra-cold vaccine storage, facilitated by high-density solutions, further secures the efficacy and longevity of vaccines.

But let’s explore these solutions in more detail.

Bioprocess containers for extreme temperatures

Bioprocess containers for extreme temperature conditions are pivotal in preserving vaccine integrity during the manufacturing journey. Consumables, such as the IRIS single-use bioprocess container by Single Use Support, are purpose-built to withstand extreme cold, ensuring vaccine stability in demanding environments.

Crafted from robust materials, these containers hold vaccines as intermediates during production from temperature variations, maintaining their efficacy throughout storage and transportation. The IRIS bioprocess container, renowned for its adaptability in ultra-low temperatures, plays a crucial role in fortifying the reliability and resilience of vaccine production workflows.

Single-use bag protection increasing vaccine handling and safety

Preserving the integrity of frozen bioprocess containers is paramount for the effectiveness of vaccines. Primary packagings are susceptible to leagages caused by temperature variations and physical stress during storage and transport. Single Use Support addresses these challenges with RoSS® Shell, a cutting-edge protective solution for all available bags.

This innovative casing, equipped with 3D foam technology, ensures a secure and insulated environment for single-use containers. RoSS® Shell's tamper-evident, closed system minimizes the risk of temperature excursions and contamination, making it a versatile and reliable choice for maintaining the cold chain integrity during vaccine storage and transportation.

Plate freezing – controlled freezing rates for optimal results

Controlled freezing rates are essential in vaccine manufacturing, influencing the efficacy and stability of the final product. These rates dictate the formation of ice crystals within the vaccine, impacting its structural integrity and potency. A controlled freezing process, powered by innovative plate freezing technology, ensures uniform ice crystal formation, preventing damage to the vaccine's molecular structure and preserving its effectiveness.

Single Use Support’s RoSS.pFTU embodies this controlled freezing concept. It is a platform offering precision in freezing processes for bioprocess containers. This technology regulates the freezing rate, maintaining a consistent and optimized environment for the vaccine.

Download our whitepaper: How controlled & scalable freezing becomes reality

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Whitepaper: How Controlled & Scalable Freezing Becomes Reality

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Freeze-thaw study protocols - Single Use Support

Ultra-cold vaccine storage with high density

Efficient ultra-low temperature storage of vaccines remains a critical aspect in preserving these biopharmaceuticals. The challenge lies in maintaining a delicate balance between maximizing storage space while ensuring consistent and ultra-low temperatures, often as low as -70°C.

Achieving this balance is essential to safeguard the potency and effectiveness of vaccines, necessitating storage solutions that offer high-density capacity without compromising temperature uniformity and control.

Single Use Support’s RoSS.FRDG stands as an innovative response to the demanding needs of ultra-cold storage for vaccine preservation. Designed as an upright ultra-cold storage freezer, its primary function centers on maintaining temperatures as low as -75°C, ensuring a consistent and regulated environment for frozen drug substances. The modular interior of the ultra low temperature freezer provides a flexible storage solution and works ideally – yet not only – with RoSS® Shell, contributing to preserving the potency of vaccines and biopharmaceuticals while optimizing storage capacity.

Cold chain solutions for vaccine manufacturing – by Single Use Support

Vaccine development hinges on the meticulous preservation of temperature-sensitive products throughout the manufacturing process. Single Use Support stands at the forefront, offering a suite of innovative, flexible and scalable solutions that revolutionize cold chain management in this domain.

From advanced bioprocess containers designed to withstand extreme temperatures to the groundbreaking RoSS® Shell, which ensures utmost protection for single-use bags, the product portfolio redefines standards of temperature control in vaccine manufacturing. These pioneering advancements not only ensure vaccine stability and security but also address critical needs for adaptability, scalability, and operational efficiency.

Freeze-thaw study protocols - Single Use Support

Alexander Fuchs

Senior Teamlead Product Line Management

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