Over 70 large, mid-sized, and small companies offer mRNA synthesis services. These providers provide mRNA modification, purification, manufacturing / scale-up, and fill/finish-related services. CDMOs who offer end-to-end mRNA services can support the development of your mRNA therapeutics and vaccine programs. This allows for consistency and shortens timelines, reducing risk and cost.
Experience
mRNA vaccines are gaining momentum in clinical development and can potentially transform a broad range of therapeutic indications. However, the mRNA industry is young, and developing vaccines at this stage requires a lot of experience in terms of streamlined development and manufacturing.
For this reason, pharmaceutical companies are relying on strategic CDMO partners to provide end-to-end support, including mRNA synthesis, cell banking, in vitro transcription, lipid nanoparticle encapsulation, and fill-finish services for GMP manufacturing. This has led to significant growth in the mRNA synthesis market during the COVID-19 pandemic.
Experience is critical to success in the mRNA manufacturing sector in this environment of heightened global demand. CDMOs like Vernal Biosciences that have built experience during the pandemic and can rapidly respond to supply chain challenges such as materials shortages and transportation shutdowns are well-positioned to lead mRNA vaccine manufacturing efforts in the future.
mRNA vaccines and therapies have the potential to revolutionize medicine by targeting previously unreachable molecules and treating difficult-to-treat diseases. Biopharma companies are partnering with experienced CDMOs to deliver the high-purity supplies they need for robust analyses, formulation, and fill-finish production to accelerate their development and speed up patient access.
Expertise
The COVID-19 pandemic accelerated interest in mRNA vaccines. Still, the rapid scale-up required to produce them placed a heavy burden on vaccine and therapeutic developers to secure supply chain capacity for the necessary raw materials, transport services, manufacturing, and storage. This allowed CDMOs to leverage their experience with the novel production process and deliver significant benefits to pharma partners.
Producing mRNA on an industrial scale requires understanding and controlling the variables that impact its multistep biosynthetic production processes (plasmid template production, in vitro transcription, mRNA purification, etc.). T
his requires significant expertise in multiple areas, including cell-free process development, reactor design, optimization of chromatography steps and ultrafiltration/diafiltration for particle size selection, and LNP formulation and Fill-to-Finish services. mRNA vaccine and therapeutic developers must find strategic partners offering complete, end-to-end project support.
This includes providing GMP-compliant raw material supply for nucleotides and enzymes, plasmid DNA production and banking, mRNA in vitro transcription, purification, and encapsulation in Lipid Nanoparticles (LNP). The right CDMO can also provide streamlined development and manufacturing services that help contain study, development, and manufacturing costs while meeting tight timeframes.
Flexibility
When an mRNA product reaches the point of analysis and formulation, developers have significantly invested money and time. Because any batch loss at this stage would be detrimental, mRNA samples must be handled and analyzed without risk of contamination and with high accuracy.
Contract development and manufacturing organizations (CDMOs) that offer comprehensive analytical testing services can help ensure quality and QC compliance across all phases of an mRNA program. The accelerated public success of mRNA vaccines during the COVID-19 pandemic has sparked interest in this emerging modality and triggered numerous mRNA projects for pharmaceutical companies.
CDMOs with deep experience in mRNA vaccines, including process development and scale-up to GMP standards, can help pharma partners develop their products faster and deliver on the promise of mRNA as a potent therapeutic.
Reliability
The mRNA space is a new and novel bioprocessing arena. Small processing volumes require single-use manufacturing components that are fit for purpose and certified RNase-free. This requirement impacted platform design, which led to a focus on closed processing operations for higher-quality outputs.
The resulting assemblies and components were often only research-grade and needed the established USP, EP, or JP quality designations seen with established commercial reagents. The right CDMO partner with one-stop solutions is essential to ensure that mRNA can rapidly progress from plasmid DNA through mRNA synthesis, IVT-mRNA, and lipid nanoparticle (LNP) encapsulation for fill-finish services.
This can eliminate a bottleneck that could delay a program and limit a developer’s ability to market their vaccine or therapeutic. mRNA is a sensitive, temperature-sensitive drug substance that must be transported, stored, and handled at ultra-low temperatures.
A CDMO partner with extensive experience handling these demanding conditions is vital to ensure the vaccine or therapeutic reaches every corner of its intended distribution network without any cold chain loss.
Efficiency
mRNA is handled at very low temperatures and requires specialized handling. CDMOs with the right technology, facilities, and expertise to meet these specific demands are well-positioned to deliver the necessary level of quality for this complex work. Developing a fully scalable mRNA manufacturing process is challenging, especially for mRNA vaccines or therapeutics.
To maximize production, a process must be broken down into a series of primary unit operations that can be easily repeated and modified in GMP conditions. The scalability of an mRNA manufacturing process depends on the chemistry and biology behind it, and there is no one-size-fits-all approach.
An mRNA CDMO with a deep understanding of these fundamentals can support cGMP development by identifying the most efficient and cost-effective way to perform a given unit operation. Taking advantage of an end-to-end mRNA service provider is critical for developers of mRNA vaccines or therapeutics. By leveraging a single provider that can support all of the critical steps in an mRNA program, developers can avoid bottlenecks and ensure their project is on track to market.
