Leading mRNA Manufacturers Supporting the Surging Demand
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Published: August 2024
The versatility and potential of mRNA technology has positioned it as a promising avenue for addressing a myriad of medical challenges and health concerns. We analyzed 42 companies that are actively engaged in offering mRNA contract manufacturing services. In this article, discover the top 5 mRNA manufacturers.
mRNA synthesis and manufacturing is a complex procedure that typically begins with the transcription of DNA templates into mRNA using enzymes (such as RNA polymerase); this is followed by purification of mRNA and further modifications in order to increase its stability and efficacy. Large scale mRNA production often employs bioreactors and automated systems to maintain the sterile conditions and optimize yield. Recent advancements in this domain, specifically driven by the mRNA vaccine manufacturing during the COVID-19 pandemic, have spurred major progress in production efficiency and scalability.
Further, the mRNA manufacturing domain is driven by several key factors, such as rising interest in mRNA-based treatments for oncological and genetic disorders, rapid technological advancements (development of automated systems and enhanced LNP encapsulation techniques) and streamlined regulatory pathways. Supporting the mRNA manufacturers are lipid nanoparticle manufacturing companies and lipid CMOs.
Roots Analysis has conducted an exhaustive study on mRNA Synthesis and Manufacturing Market featuring the current market landscape and future opportunity associated with the mRNA custom synthesis and contract manufacturing market, over the forecast period 2024-2035.
Table of Contents
Below, we have listed (in alphabetical order), the top 5 mRNA manufacturers engaged in the mRNA contract manufacturing domain:
- Curia
- Thermo Fisher Scientific
- Merck
- Aldevron
- ST Pharm
Interested in exploring all 40+ mRNA manufacturing companies across various regions?
Discover Below the Details on Top 5 mRNA Manufacturers
Let us deep dive into understanding the activity of the top 5 mRNA manufacturing companies (shortlisted based on their service strength). It is essential to note that the selection of top players can differ substantially according to the defined criteria.
Curia is Investing its Time and Resources for Improving the mRNA Production Processes
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Curia (earlier Albany Molecular Research, Inc. (AMRI)), is a contract research, development and manufacturing organization (CRDMO), providing products and services to its clients. Through its plants in California and Massachusetts, the company offers plasmid production for traditional as well as self-amplifying mRNA drug substances. Further, the firm employs its in-house research and analysis expertise to provide high-quality mRNA constructs and mRNA-based drugs, intended to treat oncological disorders, heart disorders and chronic illnesses.
To overcome the production challenges with mRNA, the company is working in collaboration with an undisclosed university to use continuous flow chemistry / continuous manufacturing work flow for mrna manufacturing.
mRNA Contract Manufacturing Service Portfolio:
The table below presents the mRNA contract manufacturing services offered by Curia.
| S. No. | Particulars | Specifications |
| 1 | Type of Service Offered | Formulation Development, Process Development, mRNA Purification, Analytical Testing and Fill / Finish |
| 2 | Type of Product Manufactured | Drug Substance and Drug Product |
| 3 | Scale of Operation | Research / Preclinical, Clinical and Commercial |
Recent Developments:
- In February 2024, Curia was awarded 2024 CDMO Leadership Award in the service category, Small Pharma group.
- In December 2023, the company was recognized as one of the top 10 CDMOs in India, by India Pharma Outlook.
- In July 2023, the company collaborated with Touchlight to provide its clients access to Touchlight’s doggybone DNA (dbDNA), thereby expanding Curia’s mRNA manufacturing offerings.
Further information on capabilities of Curia and other mRNA manufacturers is available in the full report.
Thermo Fisher Scientific, Also Offers a Portfolio of Products for Simplifying mRNA Synthesis Workflow, in Addition to mRNA Manufacturing Services
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Thermo Fisher Scientific is engaged in the development and manufacturing of life-changing therapies; notably, the firm strives to accelerate life sciences research, address complex analytical concerns, enhance productivity in their laboratories and improve patient health. The company provides different products for target gene identification and synthesis, plasmid production, in-vitro transcription and measurement of protein expression and immune response. Further, it offers manufacturing services for mRNA vaccines and therapeutics as per the needs of its customers, therefore accelerating progression from research to clinical trials to commercial manufacturing. The industry-leading brands of the firm include Applied Biosystems, Fisher Scientific, Thermo Scientific, Invitrogen, Patheon, PPD and Unity Lab Services.
In October 2022, the company launched customized Dynabeads Streptavidin for in vitro transcription and Dynabeads for carboxylic acid for RNA purification. These magnetic beads are a part of the portfolio of products for mRNA manufacturing, including TheraPure enzymes and nucleotides.
mRNA Contract Manufacturing Service Portfolio:
The table below presents the mRNA contract manufacturing services offered by Thermo Fisher Scientific.
| S. No. | Particulars | Specifications |
| 1 | Type of Service Offered | Formulation Development, Process Development, mRNA Purification, Analytical Testing, Scale-Up, Regulatory Support and Fill / Finish |
| 2 | Type of Product Manufactured | Drug Substance and Drug Product |
| 3 | Scale of Operation | Research / Preclinical, Clinical and Commercial |
Recent Developments:
- In June 2024, Thermo Fisher Scientific introduced the only fully automated maxi-scale plasmid DNA (pDNA) purification system, namely Thermo Scientific™ KingFisher™ PlasmidPro Maxi Processor* (PlasmidPro).
- In February 2024, the company was recognized for its contract manufacturing excellence through the annual CDMO Leadership awards, sponsored by Outsourced Pharma and Life Science Connect; notably, it received five awards for capabilities, compatibility, expertise, quality and reliability from three customer groups: big pharma, small pharma, and both.
- In February 2022, the company signed a 15-year agreement with Moderna to enable large-scale manufacturing of Moderna’s COVID-19 vaccine, Spikevax® and other investigational mRNA medicines, in the US.
Further information on capabilities of Thermo Fisher Scientific and other mRNA manufacturers is available in the full report.
Merck, With Strategic Acquisitions and Investment in New Facilities is on Path to Become an Integrated mRNA Service Provider
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Merck offers tools services, and digital platforms to make scientific research simpler and exact, as well as help accelerate the breakthroughs. The company has expertise in different sectors, such as Life Sciences, Healthcare (cardiology, endocrinology, immunology, neurology and oncology) and Electronics (display solutions and semi-conductors). Further, it is a contract testing, development and manufacturing organization engaged in providing integrated services for all stages of mRNA development, manufacturing and commercialization.
Merck has carefully planned its path to an integrated mRNA service provider. It includes the acquisition of AmpTec in January 2021 and Exelead in February 2022, to gain access to mRNA and lipid manufacturing technologies and expertise. The company further invested EUR 28 million at its manufacturing sites in Darmstadt and Hamburg, which support mRNA drug substance manufacturing.
mRNA Contract Manufacturing Service Portfolio:
The table below presents the mRNA contract manufacturing services offered by Merck.
| S. No. | Particulars | Specifications |
| 1 | Type of Service Offered | Formulation Development, Process Development, mRNA Purification, Analytical Testing, Scale-Up, Regulatory Support and Fill / Finish |
| 2 | Type of Product Manufactured | Drug Substance and Drug Product |
| 3 | Scale of Operation | Research / Preclinical, Clinical and Commercial |
Recent Developments:
- In July 2024, Merck signed a non-binding Memorandum of Understanding with Afrigen Biologics to support the development of an mRNA vaccine technology platform.
- In April 2024, the company invested over EUR 300 million in a new research center located in Darmstadt, Germany; further, in the center, the firm aims to research solutions to manufacture antibodies, mRNA applications and other biotechnological products.
- In September 2023, the company became the first contract testing, development and manufacturing organization (CTDMO) to provide integrated services (products and testing) for all critical stages of mRNA development, manufacturing and commercialization.
Further information on capabilities of Merck and other mRNA manufacturers is available in the full report.
Aldevron, Responding to the Customer Requirements for an End-to-End mRNA Manufacturing Process
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Aldevron has been engaged in offering high quality mRNA to its clients, since 2017. The company claims to manufacture over 70 GMP batches and has supported various Investigational New Drug (IND) submissions. Through its tailored development and manufacturing services, the firm states to have provided essential components to scientists across the globe with an aim to accelerate their research and enable discoveries that improve human health.
In May 2023, the firm announced the expansion of its mRNA production capabilities, with the inclusion of lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities from Cytiva. Till then their clients had to collaborate with a different CMO for mRNA drug product manufacturing.
mRNA Contract Manufacturing Service Portfolio:
The table below presents the mRNA contract manufacturing services offered by Aldevron.
| S. No. | Particulars | Specifications |
| 1 | Type of Service Offered | Formulation Development, Process Development, mRNA Purification, Analytical Testing, Scale-Up, Regulatory Support and Fill / Finish |
| 2 | Type of Product Manufactured | Drug Substance and Drug Product |
| 3 | Scale of Operation | Research / Preclinical, Clinical and Commercial |
Recent Developments:
- In May 2024, the company signed a partnership with Acuitas Therapeutics to incorporate the latter company’s proprietary LNP encapsulation platform and expand its mRNA-related capabilities.
- In July 2022, the firm participated in BIO International’s annual convention, held in San Diego, US.
- In January 2022 the company acquired Nature Technology Corporation to integrate the latter company’s next generation and proprietary plasmid constructs and manufacturing solutions with the former company’s portfolio.
Further information on capabilities of Aldevron and other mRNA manufacturers is available in the full report.
ST Pharm, Established an IVT-based mRNA-LNP CDMO Platform at its Banwol Production Site
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ST PHARM is dedicated towards offering one-stop service for the development of new drugs, for pharmaceutical companies globally. The company claims to have specialized capabilities in process development and mass production optimization. In addition, it offers tailored manufacturing services for the production of active pharmaceutical ingredients and intermediates. Notably, the company operates in compliance with cGMP to fulfill the expectations of its clients.
mRNA Contract Manufacturing Service Portfolio:
The table below presents the mRNA contract manufacturing services offered by ST Pharm.
| S. No. | Particulars | Specifications |
| 1 | Type of Service Offered | Formulation Development, Process Development, mRNA Purification, Analytical Testing, Scale-Up and Regulatory Support |
| 2 | Type of Product Manufactured | Drug Substance and Drug Product |
| 3 | Scale of Opation | Research / Preclinical, Clinical and Commercial |
Recent Developments:
- In November 2022, ST Pharm signed a memorandum of understanding with The International Vaccine Institute (IVI) to facilitate clinical development of a pan-coronavirus mRNA vaccine.
Further information on capabilities of ST Pharm and other mRNA manufacturers is available in the full report.
What About the Other mRNA Manufacturers?
The above presentation features the top 5 mRNA manufacturing companies selected from a pool of 42 companies that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com.
Sources:
1. “Curia collaborating with a university for continuous manufacturing of mRNA”
https://www.europeanpharmaceuticalreview.com/video/189764/continuous-flow-chemistry-from-mrna-to-small-molecules/
2. “Thermo Fisher Scientific Introduces the Only Fully Automated Plasmid Purification System to Help Accelerate Discovery and Development of Therapies”
https://newsroom.thermofisher.com/newsroom/press-releases/press-release-details/2024/Thermo-Fisher-Scientific-Introduces-the-Only-Fully-Automated-Plasmid-Purification-System-to-Help-Accelerate-Discovery-and-Development-of-Therapies/default.aspx
3. “Aldevron Announces Strategic Partnership with Acuitas Therapeutics”
https://www.aldevron.com/about-us/news/acuitas-aldevron-partnership