CDMOs with pandemic materials and transportation experiences are ideally suited to lead streamlined development and manufacturing of mRNA vaccines and therapeutics. This includes lipid nanoparticle encapsulation and fill/finish capabilities.
Customization
As the scientific world gears to tackle COVID-19, many pharma companies look beyond it for their next vaccine. Novel modalities, including mRNA-based genetic vaccines, present an exciting and high-impact opportunity for biopharma to develop lifesaving therapies. However, despite mRNA’s promise for vaccine development and clinical trials, it’s not without its challenges. For mRNA vaccine developers, finding a CDMO partner with the right expertise to support their process and scale-up needs is crucial for success. An experienced mRNA CDMO can offer an advanced staging ground for mRNA and LNP-mRNA production and several services that allow clients to focus on key drug discovery and development operations. For example, an mRNA CDMO can develop a custom process for your specific mRNA and drug substance to optimize yield and purity. An mRNA CDMO can also provide downstream processing options to suit your molecule and product requirements. For example, mRNA can be purified using a silica membrane or by process chromatography to remove salts, dsRNA, cap analogs, NTPs, proteins, and residual DNA. Moreover, a CDMO with expertise in ADC conjugation can help your company streamline mRNA-based ADC development by providing everything from the antibody and linker to the complex payload. These capabilities can distinguish between a successful ADC program and one that fails.
Integrated Project Management
Integrated project management is the coordination of a project’s elements and stakeholders. This includes everything from coordinating tasks, managing conflicts and making trade-offs to effectively communicating with team members. It also fosters collaboration between departments and teams, information sharing throughout the company, effective dependencies management and more. This approach is particularly important for mRNA CDMO because mRNA manufacturing requires working with complex processes that require precise control. In addition, mRNA is very sensitive and must be stored at ultra-low temperatures. This makes it imperative that a CDMO has the proper infrastructure and capabilities for handling mRNA in development and production. For example, a CDMO like Vernal Biosciences that provides product and GMP-compliant manufacturing services for mRNA vaccines offers cold chain storage and distribution services to deliver the final vaccine to the appropriate destination. CDMOs specializing in mRNA can support pharma companies as true partners, accelerating drug approval. This was especially evident during the COVID-19 pandemic, as mRNA-specialized CDMOs were instrumental in helping vaccine producers get their products to market faster than ever before. As a result, demand for these types of CDMOs has increased, with pharma companies seeking partnerships to help them bring innovative therapies to patients more quickly than possible without them.
In-depth knowledge of mRNA Manufacturing
The success of mRNA vaccines in the COVID-19 pandemic has fueled excitement around the platform and opened a floodgate to potential uses. mRNA therapies can target previously unreachable molecular targets, potentially treating a broad spectrum of conditions with minimal side effects and high efficacy. However, bringing an mRNA-LNP vaccine to market requires a substantial level of expertise and capacity in bioprocessing. Pharmaceutical and biopharma organizations must partner with CDMOs with the experience to support mRNA development programs from concept to clinical trials and produce mRNA at various scales for multiple steps (plasmid DNA template production, in vitro transcription, mRNA purification). To ensure purity and batch integrity, a specialized mRNA process must be developed to ensure quality and consistency, including rapid, accurate tracking of pDNA/mRNA.
Moreover, the mRNA manufacturing process must be designed to prevent the formation of cap analogs and other unwanted products during synthesis and provide flexibility for future mRNA therapeutics expansion, modification, and diversification. In addition, a comprehensive service offering is essential to support all phases of an mRNA program—from the supply of raw materials for synthesis and cell banking to plasmid template preparation, in vitro transcription, mRNA translation, lipid nanoparticle encapsulation, fill-and-finish, and final product packaging and transportation. mRNA CDMOs with broad service offerings can assure their pharmaceutical and biopharma partners of in-house scientific, manufacturing, and logistics expertise; the reliability of tightly controlled processes; and coordinated networks of facilities with high-level quality oversight.
High-Quality Reagents
As a complex molecule with a high molecular weight, mRNA requires sophisticated analytical capabilities to ensure consistency and quality. This includes impurity profiling, peptide mapping, intact protein analysis, and aggregation testing. These analyses are essential to assess mRNA vaccines and therapeutics for their safety and efficacy. For example, to evaluate the purity of mRNA, a specialized ELISA can identify any double-stranded RNA in the final mRNA solution. This is important because dsRNA could trigger an inflammatory response and potentially reduce the therapeutic benefits of your mRNA. To avoid this, mRNA CDMO uses high-quality reagents tested for dsRNA and other contaminating molecules before shipment.
Additionally, a mRNA CDMO analyzes your mRNA comprehensively. This can include characterizing the 5′ cap and poly-A tail region and assessing the mRNA’s ability to activate an innate immune response.
A mRNA CDMO that offers end-to-end services can also help eliminate bottlenecks associated with supplying raw materials and single-use components. This is done through early-stage joint communication, leveraging technical expertise from external suppliers, and expediting the forecasting and ordering process to ensure raw material readiness. The mRNA CDMO has experience working with multiple vendors, so you can focus on what matters most: your mRNA development and manufacturing program.