Building on the success of the COVID-19 vaccines, the rapid development of mRNA-based therapeutics offers not only challenges but also tremendous potential for advancing a broad range of therapeutic applications beyond vaccines. However, successful drug development requires not just the right scientific knowledge but also the right manufacturing strategy. So how do you decide? Biopharma leaders face an important decision: should you manufacture in-house, outsource to a CDMO, or adopt a blended approach? This decision hinges on your company’s unique needs, infrastructure, and goals. In this article, we’ll explore how to make the best decision for your mRNA manufacturing process by considering key factors like mRNA technology, flexibility, and costs.
The power and pitfalls of in-house manufacturing
Bringing in mRNA manufacturing in-house offers one big advantage: control
From product quality to the production timeline, in-house manufacturing offers significant control over processes, ensuring product safety, high quality, consistent critical quality attributes (CQA), and the ability to respond to challenges swiftly. For mRNA therapeutics and personalized medicines, this level of control can be significant for long-term processes, where customization, process optimization, and intellectual property (IP) protection drive competitive advantage. In-house teams have direct control over manufacturing strategy, ensuring that process development and scale-up align with product-specific requirements rather than being constrained by external platforms. There is also the potential to reduce long-term costs.
However, in-house manufacturing also comes with challenges—scaling production from lab to clinical stages requires high upfront capital investments—not just in infrastructure but also in technical expertise, raw materials, process validation, and regulatory compliance. Companies must balance operational efficiency with cost, ensuring in-house models remain sustainable and scalable while continuously evolving their capabilities to stay competitive.
That’s where digitization can help. Digitally integrated in-house facilities can streamline scale-up and reduce batch failure rates through real-time process monitoring and predictive analytics. Advanced automation and monitoring of critical process parameters (CPP) allow teams to proactively identify and correct deviations, ensuring consistency as production scales.
Technological advancements, such as modular and platform systems provide flexibility and scalability. One example is Cytiva’s NanoAssemblr™ commercial formulation system (NCFS), which supports scalable lipid nanoparticle production for mRNA therapeutics. By integrating automation mixing, in-line process monitoring, and closed system formulation, NCFS helps ensure batch-to-batch consistency while scaling early development to GMP manufacturing. Other single-use technologies and flexible platforms allow for rapid process iteration, reduced downtime, and streamlined transition, between preclinical, clinical, and commercial stages. These systems enable large-scale production without the need for infrastructure investments. Cytiva’s FlexFactory™ platform, for instance, is an agile, single-use bioprocess technology designed to accelerate mRNA production, which is a great fit for those looking to scale up quickly without significant infrastructure. These new adaptable models offer a way to lower costs while maintaining control over process innovation, formulation flexibility, manufacturing agility, and long-term strategic growth. Ultimately, in-house manufacturing isn’t just about control—it’s building adaptable, future-ready operations that can respond to evolving drug pipelines and regulatory landscape.
But let’s be real: in-house manufacturing isn’t without its challenges. Beyond the capital expenditure, managing and maintaining an in-house facility requires a skilled workforce and the capacity for continuous regulatory compliance, both of which come with significant costs and long-term investment risk. It’s a heavy lift, for emerging biotech companies or those without the right infrastructure, it could be out of reach.
Why outsourcing can be the right choice
Outsourcing to a CDMO is an attractive option for many companies, particularly, if your company is seeking specialized expertise. CDMOs have the necessary infrastructure, technology, and skilled scientists and manufacturers to help guide your product development from proof-of-concept through commercial production so you can focus on your core competencies, such as R&D, product innovation, and strategic business growth. This approach also provides financial flexibility by converting capital expenditures into operational expenses, allowing companies to free up resources for other strategic initiatives. CDMOs typically have platforms in place, which can reduce the time needed for process development and tech transfer, accelerating time-to-market. These organizations have facilities that meet GMP standards. For example, Lonza played a crucial role in supporting Moderna during the development and scaling of its COVID-19 vaccine. This collaboration enabled Moderna to ramp up production rapidly, tapping into Lonza’s extensive biomanufacturing facility without waiting for or investing in a large-scale facility [1].
Outsourcing to companies like Cytiva, which supports mRNA therapeutics development with targeted and scalable solutions, advanced technologies, and feasibility assessments, helps biopharma companies optimize processes, overcome scale-up challenges, and streamline mRNA manufacturing. Cytiva’s comprehensive nanomedicine BioPharma Services include regulatory consulting, analytical development, quality control services, ionizable lipid licensing, formulation development, downstream processing, and GMP manufacturing capabilities to accelerate the path from discovery to RNA-LNP therapeutic.
CDMOs are often experts at navigating the regulatory landscape, which can particularly be complex for the evolving mRNA vaccines and therapeutics. This reduces the administrative and operational burden. However, outsourcing can introduce risk when it comes to IP and ownership should be established upfront. The more players involved, the higher the risk of losing IP rights. Another challenge that you might face is the lead times—not just in securing capacity, but also in how quickly a CDMO can respond to process-related issues. Some CDMOs may struggle to adapt their platform to your specific needs or take longer to troubleshoot unexpected challenges, making careful selection key to success.
The flexibility of both worlds: a blended approach
What if you don’t want to choose? A blended approach might be the answer. This strategy combines in-house manufacturing with outsourcing to leverage the advantages of both models. Keeping critical stages in-house will allow you to retain control while outsourcing specialized functions such as process development, analytical characterization, testing, or scale-up production can provide access to expertise and advanced technologies. Cytiva’s Fast Trak™ process development services offer tailored support for mRNA therapeutics, helping to optimize processes, accelerate scale-up, and streamline regulatory readiness. This approach can ensure flexibility while mitigating risks associated with technology transfer and late-stage development challenges.
The flexibility provided by modular and mobile manufacturing capabilities makes the blended model more efficient. Incubator facilities, GMP hotel models, and mobile manufacturing units enable companies to lease compliant spaces for short-term production, significantly reducing both time and cost while mitigating the complexity risks associated with larger CDMO contracts. For instance, modular solutions like Cytiva’s KUBio™ platform and the innovative KUBio™ box offer plug-and-play manufacturing options that simplify scaling up or adjusting production capacity. These mobile manufacturing platforms are designed for flexibility, helping companies balance in-house control with outsourced efficiency for rapid scalability without committing to large infrastructure investments.
In-silico tools also play a significant role in streamlining this blended approach. These tools help with feasibility studies, surge production, and scale-up support, allowing you to run different production phases in parallel, accelerating the manufacturing timeline. This flexibility means that you can initiate feasibility studies, scale-up, and deployment simultaneously without compromising on quality or compliance.
In a blended strategy, companies can outsource non-core activities, such as packaging, labeling, and large-scale filling, reducing operational costs while focusing on critical R&D and quality control functions. This approach allows for a faster path to market without sacrificing control over intellectual property or key stages of manufacturing.
Incorporating the best of both worlds, a blended strategy offers flexibility, scalability, and a reduced timeline to market. However, it requires effective coordination between internal and external teams, which can introduce communication challenges like time zones/proximity challenges, potential language barriers, compliance risk (differences across countries or regions), tech transfer, and logistics complexity.
Making the right mRNA manufacturing choice
In-house production provides control, flexibility, and the ability to protect IP.
Outsourcing accelerates production timelines and offers specialized expertise but introduces potential IP risk.
The blended approach combines aspects of both worlds, offering flexibility, speed, and scalability while maintaining control over key aspects of the mRNA manufacturing process.
Each strategy offers distinctive advantages, and protecting your IP remains a top priority. With in-house you retain full control over your proprietary technologies but the more partners you work with will require a balanced approach to IP protection. Therefore, collaborating with a single end-to-end manufacturer can be beneficial and you can also reduce risk when it comes to raw materials or supply chain issues. It’s crucial to ensure that any partnership or contract includes clear terms on IP ownership, confidentiality agreements, and technology transfer clauses.
Regardless of your manufacturing strategy, collaboration is crucial. Whether you’re working in-house or with a CDMO, maintaining open lines of communication is vital to success. This becomes even more important in a blended approach. Clear roles, expectations, and regular updates ensure alignment on timelines, deliverables, and quality standards.
Pharmaceutical companies can now make informed decisions, as selecting the right strategy is no longer a binary choice. New tools and services are available to make your decision easier. With the availability of modular systems, mobile manufacturing units, and advanced tools like in-silico modeling, the decision is no longer simply about cost and capacity. It’s about selecting a solution that allows your company to be agile, efficient, and prepared for the future.
References:
- https://investors.modernatx.com/news/news-details/2020/Moderna-and-Lonza-Announce-Worldwide-Strategic-Collaboration-to-Manufacture-Modernas-Vaccine-mRNA-1273-Against-Novel-Coronavirus/default.aspx. Accessed February 18, 2025.