Achieving short-term and long-term mRNA production goals. | So Good News

The following article is an opinion piece written by Scott Ripley. The views and opinions expressed in this article are those of the author and do not necessarily reflect the official position of Technology Networks.

Preparation for future pandemics must begin now with the development of rapid vaccine production and distribution strategies. The COVID-19 pandemic has shown the importance of having a global vaccine development and manufacturing infrastructure in place. In global public health emergencies, governments; It requires coordination between academics and the life sciences industry – no single organization can do it. The development of mRNA vaccines is an example of what can be done when key stakeholders work together. However, at the same time, We also have to think about what needs to be done to meet the long-term needs of mRNA production.

Although much remains to be learned about the strengths and weaknesses of mRNA, epidemiology, There are now more than 140 clinics looking at cancer and other application areas. mRNA vaccines are potentially viable for small to medium batch sizes as well as large batches, making them suitable for personalized medicine. In addition, Since animal cells are not required, mRNA systems are faster compared to conventional systems. Because mRNA vaccines are new, they do not yet have the proven efficacy and safety of antiviral vaccines, but this may make them safer.

Combining the power of mRNA with advances like CRISPR; in vivo Cell therapy approaches and targeted intracellular antibodies open a powerful toolbox that has the potential to change the global healthcare paradigm. As we want to collaborate to accelerate the development of vaccines for COVID-19; A manufacturing ecosystem requires collaboration between industry stakeholders.

As we work to industrialize and standardize processes to meet long-term manufacturing needs; As new molecules emerge, we must ensure that they are adaptable in both scale and process. At the same time, we must prepare for future global health needs. Scientists at the Coalition for Epidemic Preparedness and Innovations (CEPI), vaccine-development companies; international organizations Representatives from academia and industry discussed what could be done to produce a vaccine within 100 days and published their findings. New England Journal of Medicine. The following five areas were identified as most important to focus on:

1. Leverage insights into new pathogens and technologies.

2. Supporting innovation in the vaccine development process.

3. Improving analytics to inform processes.

4. Promoting cooperation among stakeholders.

5. Continuous review of evidence to support approval.

A rapid vaccine development strategy is critical to global health preparedness. Current best practices must be implemented while working towards the stated objectives. Rapid testing of therapeutic candidates must also be part of the strategy. The National Institute of Allergy and Infectious Diseases (NIAID) proposed development and characterization of prototype vaccines, and program goals include:

• Identifying pathogens.
• Shortening the timeline between outbreaks and countermeasures.
• research Bridging or eliminating gaps in infrastructure and technology

Key findings from previous epidemics and pandemics have shown that poor preparedness and lack of coordination hamper the response. Standardizing simple and transferable manufacturing practices and scaling processes when necessary are key to the long-term and short-term needs of the manufacturing ecosystem for global health needs.

mRNA processing challenges

mRNA vaccines are expected to be completed within five weeks. At the same time, challenges must be overcome. One of the biggest challenges is adapting the process. Most processes have been designed and optimized for other molecules. New areas of production and development are operating; employees the process quality control; It creates pollution and other challenges and challenges.

Another challenge for mRNA is that it is much smaller than conventional cell-based modeling. This is a very attractive feature as it can save considerable space and cost, but manufacturers need to think differently about their space. Another benefit for mRNA production is that changing production parameters does not involve much risk of contamination.

DNA linearization and purification at various stages of the process is another challenge. Because of their size and different impurity profiles; Traditional chromatographic resins do not always react well with mRNA molecules. Two ways to address this challenge are greater flexibility in purification techniques, allowing process scientists to mix and match media based on the specific characteristics of the molecule. Sustained supply of raw materials and availability of GMP-grade reagents are other challenges faced by scientists.

The key to success is flexibility.

Flexible and resilient solutions are one of the key drivers for implementing an ecosystem that can respond to changing demands. Building resilient and flexible solutions allows researchers to scale quickly if needed. Currently, Limitation is one of the most common bottlenecks in mRNA production. Enabling equipment scalability and supporting the transfer from process development to GMP manufacturing is a significant achievement in building the mRNA manufacturing ecosystem.

planning to exploit the potential of therapy; evaluating material suitability; Early extraction of materials and consideration of the fill process during early stage development will help build resilience and flexibility into the process.