ThermoFisher Scientific Patheon Pharma Services
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mRNA development and manufacturing services

Flexible service offering and capacity now backed by industry experience

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.

A legacy of innovation and technical expertise

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, production 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. 

Flexible scale options to support your unique project needs

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 production projects up to 100 g.

À la carte options within an integrated service offering

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 production, 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.

 
  • Global network of expertise

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  • Process characterization studies

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  • Scale up studies

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  • Lab batches (µg to g)
mRNA Process and Analytical Development
 
  • Standard analytical, in-process, and release testing

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  • cGMP method transfers, validations, and stability studies

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  • Analytical capabilities continuously expanding, with ability to adapt to customer needs

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mRNA GMP Manufacturing
 
  • Three process trains for synthesis and purification; up to 100g mRNA/batch scale

  • Two lipid nanoparticle formulation areas; 500L working volumes

  • 15 kg/year max capacity

  • Clinical to commercial

  • Dedicated HVAC and utilities
cGMP Manufacturing

 

View our infographic for an overview of a standard mRNA manufacturing workflow and insights on how Thermo Fisher Scientific can support each step.

Technology transfer is often associated with risks that may affect costs and timelines. To circumvent these challenges, we employ a methodical and risk-based tech transfer approach leveraging 30+ years of Patheon manufacturing experience. Our teams are well-versed in all aspects of tech transfer including scaling, moving projects between facilities, and transferring external processes into our facilities. We can execute the transfer quickly and effectively to keep your project on track and preserve supply. Our flexible approach is driven by your deadlines, and we’re dedicated to getting the job done right the first time.

 
  • Standardized tech transfer across sites
  • Multidisciplinary project team with experience managing 200+ transfers to date

  • Clear line of sight from process development through cGMP

  • Risk management tools to identify and mitigate risks

  • Process simulation modeling available

  • Compartmentalized area for staging and prepping

  • Follow Technology Transfer Protocol (TTP)
    • Document all key process details
    • Criticality ranking
    • Updated as process moves through clinical manufacturing and converts into process control strategy for PPQ

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.

 
  • CMC dossier writing

  • Gap analysis and CMC dossier review

  • CMC regulatory strategic consulting

  • Health authority meeting, filing, and inspection support

  • Familiarity with shifting regulatory guidelines

LNP capabilities and libraries

Our team can propose an LNP strategy from process and analytical development to cGMP manufacturing using either microfluidic or t-mixing technologies. As the Monza site does not have a proprietary LNP platform, we are agnostic to lipid technology and can develop a solution that works best for your unique mRNA project needs.

Visit our mRNA manufacturing site in Monza, Italy

 

Our 642,000 sq ft campus in Monza, Italy is a center of excellence for sterile manufacturing. It features a unique co-location of mRNA manufacturing capabilities with LNP and fill finish services to help streamline your processes and mitigate risk. 

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