The rapid development and approval of mRNA-based vaccines during the COVID-19 pandemic has spurred a renewed interest in mRNA technology, creating market constraints on access to critical raw materials and manufacturing capacity. Thermo Fisher Scientific has responded quickly by ramping up a flexible solutions model for mRNA vaccine and therapeutic development that spans the entire operational value chain, from plasmid production to cold chain logistics. Save time and costs with our end-to-end solutions that provide support from early clinical phases through commercialization.
We bring 30+ years of sterile fill finish, biologics, and advanced therapy manufacturing experience, with a proven track record of bringing molecules from concept to commercialization. From 2013 to 2022, Thermo Fisher Scientific received more NDA/BLA approvals than the next two CDMOs combined. This same technical expertise and robust global quality systems are leveraged in our new mRNA service offering to help you optimize product performance and accelerate time to market.
With an increasing number of clinical applications for mRNA technology ranging from oncology to rare disease and personalized medicine, production volume requirements may vary greatly. To address this evolving need, we offer flexible scale options to support both smaller volume requests and larger projects up to 100 g.
Combining a flexible approach to development and manufacturing with critical foundational capabilities like comprehensive analytics and regulatory support provides the speed required to succeed in today’s rapidly evolving mRNA market. From process development to cGMP, you can choose from our core mRNA service options and add upstream and downstream solutions as needed. Leverage our full suite of integrated services or just choose those that help fill immediate gaps in your capabilities or capacity. Additionally, we can accommodate your existing mRNA processes or help you utilize in-house processes developed at our Monza center of excellence.
The regulatory landscape for advanced therapies is constantly evolving, and what’s acceptable today may not be adequate tomorrow. For over 15 years we have supported customers with global regulatory interactions (US, EU, and Canada), CMC regulations, guidelines, and inspections. In addition to providing document reviews and gap analyses, our regulatory services team can generate documents to reduce the number of intermediaries and lead times in preparing regulatory filings.
Addressing industry challenges in mRNA product commercialization
The rapid development and approval of mRNA-based vaccines during the COVID-19 pandemic has spurred a renewed interest in mRNA technology, with scientists exploring new application areas such as oncology, HIV, rare diseases, and even personalized medicine. While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use. Learn more.Watch Webinar
mRNA manufacturing workflow
Like many therapeutic manufacturing workflows, every step in the mRNA process builds upon the prior step. This infographic explores each intertwined step in the mRNA manufacturing process and outlines how Thermo Fisher Scientific’s flexible approach can get your mRNA product to clinic and market faster.View Infographic
mRNA Manufacturing Services
Thermo Fisher Scientific understands pharmaceutical services and has worked to integrate our capabilities across the nucleic acids operational value chain to enable you to move your mRNA therapeutic from development to commercialization. Learn more about our mRNA manufacturing services.View Fact Sheet