5 Key Benefits of Utilizing a CDMO for FLuc mRNA Development
In response to the COVID-19 pandemic, mRNA vaccines quickly became effective. This sparked a wave of biotech and pharmaceutical innovation. This has fueled the growth of the mRNA contract development and manufacturing (CDMO) market. With the right CDMO partner, pharmaceutical and biotech companies can promptly achieve their mRNA therapeutics and vaccine goals.
Enhanced Productivity
As mRNA vaccines and therapeutics continue to make headlines for their successful pandemic use, the contract development and manufacturing (CDMO) market for these next-generation products is growing rapidly. With revenues fueled by COVID-19 vaccine sales, the rapid expansion of mRNA-based products is fuelling the need for new CDMOs to scale up quickly and expand capacity.
The mRNA industry also requires a robust cold chain logistics system to safeguard and secure mRNA products throughout the supply and distribution chain. With broad service offerings, mRNA CDMOs can de-risk a project’s research and clinical supplies with an advanced staging ground. With their experience during the pandemic, materials shortages, and transportation shutdowns, CDMOs like Vernal Biosciences can deliver value by enabling their pharma partners to efficiently bring mRNA-based therapies to market. As a result, they can allow more patients to benefit from these life-changing innovations.
Reduced Risk
As a novel modality, mRNA has the potential to revolutionize medicine. By targeting complex genetic pathways, mRNA can provide therapeutics for difficult-to-treat diseases. Furthermore, mRNA can be incorporated into lipid nanoparticles, which protect it from enzymatic attack and enhance its cell uptake and expression by 1000-fold. This means mRNA-based vaccines can effectively be delivered to the disease site to treat the disorder’s underlying cause.
This has been demonstrated by the rapid development of mRNA-based SARS-CoV-2 vaccines, developed by Moderna and Providence Therapeutics, that are now in clinical trials for patients with COVID-19. This success was achieved through partnerships with strategic CDMOs that could offer end-to-end support, including mRNA synthesis and lipid nanoparticle encapsulation capabilities, plasmid DNA synthesis, in vitro transcription, and fill and finish services. Additionally, working with a CDMO that can deliver high-purity mRNA on a transactional basis is a critical piece of the equation. This can help accelerate process development by reducing the risk of batch failure and enabling data-driven justification to mitigate risks to the final product.
Increased Flexibility
The mRNA synthesis and manufacturing services market is growing rapidly, focusing on developing next-generation vaccines, therapeutics, and diagnostics. This new technology promises to revolutionize the pharmaceutical industry by targeting difficult-to-treat diseases with unprecedented speed, effectiveness, and safety. The COVID-19 pandemic drove a significant increase in the development and manufacture of mRNA-based vaccines, with several highly effective candidates entering clinical trials.
These successes have prompted pharma and biotech companies to accelerate their pipelines of therapeutics based on this novel modality. However, mRNA vaccines present unique challenges that require a highly flexible, specialized CDMO partner. This includes a robust supply chain, cold storage capabilities, specialized aseptic fill-finish technology, and a technical analytical lab with specific instrumentation required to meet the demands of this fast-paced new manufacturing landscape.
Increased Efficiency
The COVID-19 pandemic accelerated interest in mRNA vaccines and therapies, and the industry continues to see strong demand for these technologies. As the mRNA market grows, biopharma and pharmaceutical organizations need a CDMO partner to provide comprehensive end-to-end services to streamline their mRNA development and manufacturing process. A true mRNA CDMO can help speed the development process by providing expertise and a highly scalable cGMP-compliant process that is fit for developing mRNA drugs and vaccines.
A one-stop solution provider can also reduce overall costs by eliminating the need to manage multiple providers and coordinate efforts. Additionally, an experienced mRNA CDMO can support specific requirements of the mRNA space, such as cold chain storage and handling, and ensure that developed mRNA drugs, vaccines, and other therapeutics meet the required quality targets once they are ready to be released for clinical use. This key factor will ensure the development of high-quality mRNA products. This will ensure that the mRNA product is safe for patient administration and will perform as intended in the body.
Reduced Costs
The development of mRNA therapies and vaccines has the potential to alter how different diseases are treated today completely. These therapies can treat various indications, including cancer, respiratory infections, metabolic and cardiovascular disorders, and rare genetic conditions. mRNA can be faster than traditional vaccine development and manufacturing methods, typically based on inactivated vaccines. mRNA production processes also offer greater flexibility, with the ability to produce multiple vaccines or therapeutics in one line.
Using an mRNA CDMO can help to reduce the costs associated with the production process. This is because mRNA costs depend on several factors, such as the number of steps in the synthesis, purification, and formulation process. By understanding the impact of these unit operations, manufacturers can identify areas where they can optimize mRNA production and reduce overall costs. The mRNA Contract Development and Manufacturing (CDMO) market is expected to grow significantly in the coming years. This is largely because many large pharmaceutical companies plan to launch various mRNA-based vaccines and therapeutics.
