What’s old is new again. Ever since the 1970s, when Hungarian scientist Katalin Karikó was engaged with researching mRNA, the medical world has struggled with the mRNA molecule’s instability. These challenges, in terms of both in vivo delivery and toxicity and ex vivo storage and transportation, severely limited its practical applications.
Recently, however, scientists have overcome some of these hurdles to deliver two COVID-19 vaccine wins. The success of Moderna’s and Pfizer-BioNTech’s mRNA vaccines has intensified the spotlight on this previously dormant innovation. In addition to showcasing mRNA’s tremendous clinical efficacy, these vaccines have triggered numerous technological advances across the pharma value chain, particularly in vaccine development.
mRNA has become the closest thing we have to “digital” medicine, as it’s essentially a set of instructions to the body to produce a specific type of protein, akin to meticulously coded software. This unique feature not only makes the mRNA molecule scalable across multiple therapeutic areas, but it also introduces opportunities for developing reusable cross-therapeutic discovery, manufacturing and supply chain platforms.
Capitalizing on the mRNA opportunity
These advancements will not happen in a vacuum. While mRNA could fundamentally change the way drugs are researched, developed, manufactured, distributed and adopted, such changes will require technological advancement and investment across the pharma value chain.
We envision three areas that are poised for advancement, and advise life sciences organizations to invest accordingly if they want to capitalize on the mRNA opportunity.
- The emergence of bio-platforms. The biggest mRNA opportunity lies in the molecule’s plug-and-play nature, which allows for the creation of programmable medicines. For example, the Moderna and Pfizer-BioNTech mRNA sequencing platforms — initially targeting other infectious diseases and cancer, respectively — were both quickly repurposed to develop COVID-19 vaccines early in the pandemic.
This success could usher in an era of bio platforms that engineer mRNAs, genes and cells to create programmable medicine. Subsequently, this could introduce life sciences companies to the concept of horizontal industrial infrastructure. The industry is gradually moving toward building and sharing modular components and measurement technologies, while also developing interfaces that can be swapped and combined across a wide range of therapeutic areas.
We could soon see a burgeoning market of plug-and-play components like molecule delivery platforms, gene sequencing platforms, sensors and cellular switches, followed closely by demand for modular measurement technology platforms.
Central to the concept of horizontal infrastructure is a highly interconnected environment, big data management and analytics, scalable computing and shared learning. With these goals in mind, life sciences businesses must consider adopting a robust and modern IT infrastructure to equip them to horizontally integrate their modules efficiently.
Moderna, for instance, has partnered with Amazon Web Services (AWS) to host its Drug Design Studio application, an online catalog of proteins that serve as starting points for developing mRNA therapies. In another instance, Bristol-Myers Squibb has built enterprise data lakes on AWS to improve its scalability and improve their speed of data ingestion and transformation to be used across multiple therapeutic areas.
- Increased use of digital twins in vaccine development and production. The demand pressures spurred by the pandemic — scaling mRNA vaccine production and accelerating its time-to-market — opened the doors for increased use of digital twin technology. Digital twins, which are live, virtual replicas of the drug development process, serve the dual purpose of monitoring quality through continual optimization and enabling manufacturing capacity multiplications of the production process across different geographies.
The digital twin trend’s momentum is likely to continue thanks to rapidly evolving simulation and modeling capabilities, better interoperability and IoT sensors, and wider availability of tools and computing infrastructure.
Sanofi Pasteur, for example, has accelerated the conceptual design of its “Evolutive Vaccine Facility” using digital twin technologies. The vaccines division of the French multinational pharmaceutical company is using HakoBio, a web 3D platform, to enable teams to visualize the facility layout, reduce design risks and evaluate process feasibility within the space.
- Advances in cold-chain logistics. The biopharmaceutical industry has already established cold supply chains for maintaining biologic drugs at required temperatures. However, the industry was not prepared for the urgent, large-scale distribution and tracking complexities of mRNA COVID-19 vaccines. This challenge is especially apparent in developing countries with less mature cold-chain systems.
A leap in technological ingenuity is needed to establish a robust, end-to-end cold-chain system worldwide that can sustain the momentum of innovations in vaccine development. Three key technologies are gaining traction in this regard:
- Digital enablers delivered as a service. The integration of new container/packaging technologies, advanced sensor technologies and real-time data analytics has helped to create a digital cold-chain transportation network designed for time-critical logistics. IoT sensors analyze transportation routes while capturing and transmitting environmental monitoring data and temperature excursions. GPS-enabled sensors — embedded at the package level, as opposed to the overall shipment level — communicate the temperature and condition of shipments with more granularity.
- Blockchain as a trusted network to track and trace. Blockchain is a promising technology for sharing sensitive product data across multiple businesses in the pharma cold chain. It provides a trusted network for consistent communication with high levels of integrity between drug suppliers, logistics partners and the end customer. It can help companies eliminate errors and miscommunications when it comes to time-critical tasks such as drug tracking and tracing, while averting product damage through environmental tracking and proactive intervention.
- AI-powered optimization of shipping decisions. AI-enabled simulation software platforms are paving the way for more sophisticated shipping protocol validation, helping the industry move away from the reactive use of data loggers to simulate shipping conditions and toward proactively identifying potential problems and optimizing routes. These platforms can simultaneously simulate worst-case scenarios for the five key distribution hazards — temperature, vibration, shock events, pressure and humidity — to enable enhanced shipping preparedness and monitoring protocols.
Riding the innovation wave
As mRNA research matures, the drug development process will not only accelerate — it will also become more modular and data intensive. The technological innovations across the pharma value chain that enable these novel therapies are bound to grow accordingly.
To keep pace in this accelerated innovation environment, pharma companies need to not only expand their use of emerging technologies like bio-platforms, digital twins, IoT and blockchain but to also continuously upgrade the relevant facets of their value chain to support them. When it comes to developing transformative mRNA therapies, a robust technology infrastructure is as essential as the science of the mRNA molecule itself.
Bhupendar Saggu (Cognizant Consulting Life Sciences Japan Practice), Sangeetha Arumugam and Debanshu Mukherjee (Cognizant Consulting Life Sciences India Practice) also contributed to this blog post.