December 11, 2023
Vaccine development and manufacturing are a challenging business and in order to be efficient and successful manufacturers will have to adopt advanced technologies. The obstacles are manifold and the fragility of supply chains or requirements in cold chain management are just two of the challenges in vaccine manufacturing.
Single-use technologies prove to be particularly suitable when it comes to dealing with highly sensitive and expensive materials that need to be handled not only with care but also in sterile conditions. In addition, those technologies provide the flexibility and agility needed in an industry that relies on the possibility to scale up on demand.
While the challenges in vaccine development may differ according to the respective product and the parties involved in vaccine development and production, there are several hurdles that apply globally.
Main challenges in vaccine manufacturing:
Not only is the development of effective vaccine candidates highly complex, but it also comes with a hefty price tag. To improve efficiency, there needs to be a collaborative effort between regulatory bodies, vaccine manufacturers, healthcare providers and public health organizations.
High costs are without a doubt one of the most challenging hurdles in vaccinology, both in terms of the development of candidate vaccines and manufacturing. Extensive R & D and preclinical or clinical trials, regulatory approvals and quality control, as well as the necessary technology and infrastructure all contribute to those high costs.
The nature of vaccine research, development and production calls for processes and systems that allow for scale-up for large-scale production runs of vaccine doses. This can be achieved by implementing adaptable platforms and systems that allow for a high degree of flexibility.
The implementation of technologies that offer agility and flexibility can reduce the cost of vaccine manufacturing in the long run. Efficient scalable solutions from development in laboratories to production sites reduce costs through lower error rates, product loss and optimized usage of resources.
And finally, an effective cold chain can help to reduce further operational costs. Advanced cold chain solutions for vaccines minimize the risk for contamination and maintain vaccine efficacy – to remain capable of neutralizing antibodies or protecting our immune systems.
Given the fact that vaccines are crucial in preventing the spread of infectious diseases like the Coronavirus or hepatitis, it will be essential to generally curb costs, for instance by advanced production technologies or cooperations to enable cost-efficient research, production and distribution.
Sustainability in vaccine manufacturing poses a multifaceted challenge that demands a balance between meeting global healthcare needs and minimizing environmental impact.
The traditional vaccine production process often relies on resource-intensive methods, such as extensive water and energy consumption. To sustainably develop and manufacture vaccines, there is a growing need to adopt greener technologies and practices. This shift involves exploring alternative, eco-friendly production methods, reducing waste generation, and implementing energy-efficient processes.
Embracing single-use technology represents a sustainable solution for vaccine manufacturing, offering a viable alternative to traditional stainless steel equipment. Numerous life cycle assessment studies have consistently demonstrated that transitioning from stainless steel to single-use systems within the biopharma and pharma industry can lead to substantial reductions in carbon emissions, as well as lower energy and water consumption.
A key contributing factor to these environmental benefits is the diminished need for extensive cleaning processes associated with stainless steel equipment. Moreover, the adoption of single-use technology enhances operational flexibility and minimizes the risk of cross-contamination.1 2
Efficiency is another major challenge in the vaccine design, development and production of new formulations – and it is one of the main factors contributing to high costs. It is thus crucial to address and improve efficiency, both in development and production.
Efficiency encompasses both the speed and quality in the development of new vaccines in the laboratory, as well as the effectiveness of production processes. Enhanced quality and rapid, safe procedures contribute to heightened efficiency and success in the global vaccine market.
Manual processing still constitutes bottlenecks in certain stages. Human intervention poses a risk of contamination, potentially resulting in the loss of valuable substances. Therefore, implementing automated fluid management solutions is a crucial strategy to elevate quality, accelerate processing, and ultimately enhance overall efficiency.
Single Use Support’s technologies offer viable solutions that are both integrable and scalable to address challenges on several fronts. By eliminating the need for manual processing and handling, they reduce
In addition, they ease and streamline processes by replacing rigid stainless-steel containers with adaptive single-use consumables that can easily be integrated in existing processes across various platforms.
Once a new vaccine has been given the green light by the Food and Drug Administration (FDA) and other regulatory bodies, vaccine manufacturers are faced with the challenge of scaling up their processes.
This specific challenge became most evident during the high time of the Coronavirus disease when formulations were required in large scale as soon as they had passed phase 3 trials and adverse events could be ruled out.
But even beyond the pandemic, scaling remains an important topic. Once a formulation is approved, titers of raw material need to be bumped up. Raw material includes antibodies, RNA, various viral vectors, pathogens or adjuvants to boost immune response and increase the duration of antibody responses.
In addition to having to handle increased volumes of raw material, large scale vaccine platforms require an increasing amount of components, many of which are often provided by different suppliers. Any issues in the procurement of just a single component will stall the production of valuable vaccine doses, thus impacting the global health sector.
Furthermore, standardization is an essential aspect in scaling up vaccine manufacturing. The FDA approval and clinical phases rely on findings from small volumes. When scaling up the quantity of substances, minimizing deviations becomes imperative to guarantee both efficacy and, more importantly, safety. To attain the desired properties, scalable processes—from laboratory procedures to the handling of bulk drug substances—need to adhere to a certain degree of standardization. In addressing this challenge, the solutions from Single Use Support, ensure freezing curves that maintain uniformity or similarity for both small and large volumes.
Another significant aspect in scaling up production involves establishing a well-functioning supply chain for all essential components, with particular emphasis on ensuring the security of cold chain logistics.
Given the fact that the half-life of a vaccine correlates to the temperature it is stored at, the importance of a functioning cold chain management becomes apparent. This is especially true with regards to highly sensitive vaccines, such as mRNA vaccines. It is somewhat surprising that cold chain management is an area with plenty of room for improvement.
According to a study published in The Lancet, “the cold chain is often compromised by insufficient supporting infrastructure or staff, especially in resource-constrained environments. Add to that constraints in space and a patchwork of logistics partners that all employ different technologies, and cold chain management quickly seems like an insurmountable challenge.
However, it does not have to be this way: Single-use technologies facilitate end-to-end solutions that meet the specific needs of both cold chain storage and handling. Single-use systems are universally applicable for different drug products – be it mAbs, ADC or mRNA vaccine. Not only are those solutions tamper-proof, but they also allow for monitored temperature control as well as tracking throughout shipping and storage.3
Single-use technologies have been mentioned as a promising solution in addressing several of the challenges faced by vaccine manufacturers. From sterile consumables to ultra-cold storage and cryogenic freezers they cover every stage of the vaccine manufacturing process.
At the core of the system is the RoSS® Shell, a secondary packaging designed to protect single-use bags containing the highly valuable substances. The bioprocess containers are protected inside the RoSS shell throughout process steps in fluid and cold chain logistics. Liquid management occurs with a seamless process from homogenization to filling into single-use bags and freezing, eliminating the need for manual handling.
Single Use Support offers automated end-to-end systems with platforms for
In addition to being flexible and scalable by nature, they all allow for intuitive integration with existing manufacturing execution systems. They protect and secure everything from minuscule amounts of T-Cells to virus-like particles and large volumes of recombinant material required for vaccines against the various variants of Sars-Cov-2, and other infectious diseases.
They contribute to a safe journey and warrant the content’s intact arrival at its final destination. In other words: Advanced adaptive technologies are indispensable in order to safeguard the protected handling of highly valuable and sensitive vaccines. They help to improve efficiency while at the same time reducing human errors, ergo product loss and costs.
Challenges in vaccine manufacturing include complex production processes, stringent quality control, scalability issues, and the need for specialized facilities, which all contribute to high costs in vaccine production. Supply chain disruptions, regulatory hurdles, and emerging variants also pose ongoing challenges.
Immunogenicity, which refers to the ability of a substance like antigens or a vaccine to provoke an immune response in an organism, is a key characteristic in the development of vaccines.
In the field of immunology and genomic research, various viral vectors play a crucial role in vaccine development. Commonly utilized vectors include Adenovirus, Adeno-associated virus, Herpes simplex virus, measles virus, and retrovirus vectors. The development process typically integrates a combination of in vitro, ex vivo, and in vivo approaches. According to a study accessible on PubMed, "Adenoviruses are efficacious vaccine vectors against diseases in which traditional vaccine development strategies have proven ineffective. Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4847555/
Global health partnerships have been established to support expensive vaccination programs worldwide. A current example would be Gavi, a vaccine alliance initiated by the World Health Organization (WHO) and different other stakeholders. Its aim is to increase and improve access to immunization in low income nations, such as the majority of countries in Africa.
While the largest exporters of vaccine products are the European Union, India, China and the USA, the European Union is the leading global supplier. According to an article published on JAMA, to this date global vaccine distribution is highly inequitable, with middle- and low-income countries often “... receiving proportionally less vaccine than high-income countries”. Source: https://jamanetwork.com/journals/jama/article-abstract/2799644
Director New Products, Innovation & Product Line Management
