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The evolving mRNA landscape has been marked by rapid advancements and a broadening scope of applications, primarily driven by the success of mRNA vaccines during the Covid-19 pandemic. mRNA-based vaccines, which instruct cells to produce specific proteins for disease prevention or treatment, show great promise in precision medicine for treating infectious diseases, genetic disorders, and cancers.

The pandemic, while presenting significant challenges globally, showcased the effectiveness of mRNA technology in vaccine development, highlighting its rapid production, precise immune targeting and streamlined manufacturing processes. Since then, pharma companies have invested heavily in mRNA therapeutics development; global sales for mRNA-based pharmaceuticals are projected to reach $26.2bn by 2030, according to GlobalData’s Drugs Database[i].

Many assets are still in pre-clinical stages, with rapid clinical research and ongoing innovation in process development and manufacturing technologies. Rising research focus areas include different mRNA lengths, base modifications, circular RNAs and lipid compositions. Emerging application trends include strong growth in oncology, increasing interest in protein replacement therapies and potential for in vivo cell therapies.

Ongoing research and innovation has highlighted the complexity of mRNA interactions, such as those between mRNA and microRNAs, which play critical roles in regulating mRNA stability and function. Research groups are now characterizing the transcriptome in various diseases, including atherosclerosis, to identify potential biomarkers and therapeutic targets. Further, initiatives such as the mRNA Technology Transfer Program[iii] aim to establish sustainable vaccine manufacturing ecosystems in low- and middle-income countries, enhancing global health equity.

The mRNA technology landscape’s evolution beyond vaccines indicates a growing confidence in the technology’s potential for various therapeutic applications. However, as the market opens up, it brings production challenges. Moving forward, the key focus will be on developing more efficient, flexible, and cost-effective manufacturing platforms that can adapt to the evolving mRNA therapeutic landscape.

Modular mRNA production

The production of mRNA faces several challenges. These include high costs due to expensive raw materials, high reagent costs for in vitro transcription (IVT), and limited economies of scale compared to traditional biologics. Additionally, processes are highly complex, with diverse product requirements and varying lipid compositions requiring unique purification strategies.

In terms of manufacturing limitations, issues include scalability, temperature control challenges, and short reaction timeframes. Technical challenges, like optimizing IVT efficiency, managing RNA secondary structures and ensuring consistent yield and quality must all be addressed, in addition to developing predictive models for process optimization. As pressure to reduce overall production costs continue, future production demands will likely include increasing flexibility to address different patient populations or therapeutic targets and increasing manufacturing efficiency.

In answer to these challenges, and as the industry seeks to refine and futureproof its models of production, modular manufacturing is emerging as a key solution. Modular systems allow for the customization of production lines without the need for extensive modifications to existing infrastructure, so that pharmaceutical companies can quickly adapt their manufacturing capabilities to meet the specific demands of individual vaccines. This method utilizes standardized, off-the-shelf functional modules that enhance operational efficiency while ensuring compliance with good manufacturing practices (GMP).

In a recent webinar, The next frontier in mRNA modular manufacturing for scalable RNA-LNP therapies, Linda Mathiasson, strategic customer leader for Cytiva, discussed the rapidly evolving RNA field and how a modular platform solution offers flexibility, scalability and potential for automation in production. “Standardized, modular solutions will be the key to ensure sustainable investments in manufacturing,” says Mathiasson, “because, when needs change over time, it will bring you flexibility by keeping speed. At Cytiva, our mission is to advance and accelerate therapeutics, and we’re doing that by developing tools and services and solutions for research process development and manufacturing of genomic medicines and other biologics.”

Mathiasson says that different applications reflect different challenges and needs: “We must continue working closely together with industry and academia to innovate and develop the tools, the technologies, the services, to make it possible to commercially manufacture these therapeutics, and this includes having scalable manufacturing solutions.”

The flexibility of modular production

What does a modular setup offer that other solutions do not? Crucially, flexibility. As the scope of mRNA therapeutics widens, biomanufacturers need to be able to adapt quickly. With modular platforms, they can — keeping the workforce familiar with manufacturing pipelines while also supporting efficient production of any type of molecule.

Investing in modular production can also lower capital costs. This is achievable through, for example, reduced risks of batch loss due to cross-contamination and the elimination of extensive cleaning operations.

Shorter delivery times and better process flexibility are two further benefits of modular platforms. They enable a rapid response to market demands — particularly in public health emergencies such as the pandemic — with the ability to respond rapidly to emerging needs and changing objectives.

The future of personalized medicines

Current manufacturing approaches can make personalized therapies prohibitively expensive. However, the rise of adaptable production platforms and modular tools offer opportunities for introducing automation and predictive modeling. Intensifying manufacturing processes, optimizing the IVT stages, and developing more efficient purification strategies could all help enable rapid, patient-specific RNA-LNP production. Manufacturing pods could be used to create various lines in a single facility, with the goal of making personalized mRNA vaccines economically and technologically feasible. Somewhere down the road, we might even see the promotion of personalized vaccines from last-resort to first-line treatments.

Because of its many advantages in both clinical and manufacturing settings, mRNA has the potential to bring about a revolution in the treatment and prevention of diseases. However, mRNA-LNP therapies are precise and targeted, requiring high levels of expertise. This is where Cytiva comes in. They provide end-to-end, adaptable solutions that can support the evolving mRNA manufacturing landscape, from research through to commercial production — including modular manufacturing solutions. Cytiva has a track record of accelerating growth, productivity and innovation in the personalized biological therapies sector, with facilities across Asia, Europe, and the Americas.

For further information on how Cytiva can help you to avoid process and regulatory pitfalls and implement solutions and strategies to advance your mRNA therapeutics, fill in your details on this page.

[i] /analyst-comment/mrna-licensing-agreements-double-with-million-dollar-deals/

[ii] GlobalData, Analyst Briefing, “mRNA Licensing Agreements Double with Million-Dollar Deals in 2024,” October 2024.

[iii]

Free On Demand Webinar

Promise and Innovation in Modular mRNA Manufacturing

Download this free webinar today and learn how modular manufacturing platforms are enabling the next phase of mRNA and LNP therapeutic development. Coordinated by industry leaders Cytiva, it shares how flexible infrastructure and standardized systems are helping companies scale from early development to GMP production efficiently. Executives will gain new perspectives on how evolving platform technologies support a broader therapeutic pipeline, improve cost dynamics and prepare facilities to meet future clinical and commercial demands.

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