Published: September 2023
Top plasmid manufacturers have been meticulously selected based on a proprietary company competitiveness analysis, taking into consideration their portfolio strength and recent initiatives. These companies are instrumental in meeting the growing demand for plasmid DNA manufacturing. We analyzed a comprehensive list of plasmid manufacturers that have the required capabilities to manufacture plasmid DNA across various scales of operation. In this article, discover 10 leading plasmid manufacturers and their capabilities in this industry.
Plasmid DNA plays a vital role in the development and production of Advanced Therapy Medicinal Products (ATMPs), including cell and gene therapy products and DNA vaccines. It acts as a carrier, delivering therapeutic genes and vaccine antigens into target cells, enabling personalized treatment and innovative disease prevention strategies. The recent success of COVID-19 vaccines, such as Pfizer-BioNTech's Comirnaty, Moderna's Spikevax®, and Gennova Biopharmaceuticals’s GEMCOVAC™-19, which rely on plasmid DNA, has underscored the significance of plasmid DNA in the biopharmaceutical industry. However, the plasmid DNA manufacturing process, which often requires Escherichia coli bacteria, is complex and susceptible to impurities and genetic variations that could compromise the safety and efficacy of these therapies. Moreover, scaling up plasmid manufacturing requires specialized equipment and highly controlled Good Manufacturing Practices (GMP) compliant suites, resulting in higher production costs.
To address these challenges, plasmid manufacturers have emerged as indispensable partner for biopharmaceutical drug developers aiming to capitalize on the plasmid-based therapy market's potential. This strategic alliance allows pharmaceutical companies to leverage the specialized capabilities of plasmid DNA manufacturing companies, reducing development timelines and enabling faster market entry. In addition, recent trends in the plasmid DNA manufacturing market indicate that plasmid manufacturers are adopting novel plasmid backbone modification technologies to improve plasmid DNA vector design and increase overall pDNA manufacturing efficiency by several folds. It is also becoming increasingly important for plasmid manufacturers to invest in flexible and automated technologies, in order to combat the challenges associated human intervention in the plasmid production process, such as introduction of impurities that can lead to genetic variations. Consecutively, players in this domain have undertaken various expansion initiatives to develop and implement several novel and more productive operating protocols, as well as optimize current plasmid production process. Leading plasmid manufacturers, including Thermo Fisher Scientific, Charles River Laboratories, and Aldevron, are at the forefront of these advancements, reinforcing their commitment to the evolving landscape.
Roots Analysis has conducted an exhaustive study on Plasmid DNA Manufacturing Market featuring the current market landscape, market size and future opportunity for the plasmid manufacturers, over a span of 12 years.
As the plasmid DNA manufacturing market continues to expand, with North America as a prominent hub of plasmid manufacturers, the partnership between drug developers and plasmid manufacturers will play a pivotal role in catalyzing market growth and shaping the future of cell therapy, gene therapy and mRNA therapeutic and vaccine industry.
The top plasmid manufacturers are listed below (in alphabetical order):
1. AGC Biologics
2. Aldevron (acquired by Danaher)
3. Catalent Pharma Solutions
4. Centre for Breakthrough Medicines (CBM)
5. Charles River Laboratories
6. GenScript ProBio (a subsidiary of GenScript)
7. PackGene
8. Thermo Fisher Scientific
9. VGXI
10. WuXi ATU (a subsidiary of WuXi AppTec)
Interested in exploring all Plasmid Manufacturers, their manufacturing facilities and capabilities?
This article highlights the top 10 plasmid manufacturers to watch out for in this industry. These companies were chosen based on proprietary company competitiveness analysis, taking into consideration their portfolio strength and recent initiatives. It is essential to note that the selection of top players can differ substantially according to the defined criteria(s).
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Aldevron, is US-based CDMO that claims to offer various services for the manufacturing of plasmid DNA, proteins, enzymes and other biologics, for research, clinical and commercial applications. With an experience of more than 20 years, the firm offers a wide range of services related to plasmid production, including plasmid design, manufacturing, purification and analytical testing. Additionally, Aldevron has developed proprietary manufacturing technologies that enable the production of GMP plasmid DNA in a scalable and cost-effective manner.
The company’s Nanoplasmid® Vector Platform has been used by Moderna for its mRNA vaccines. The nanoplasmids have a smaller backbone than the standard plasmids and are free of antibiotic markers.1
In August 2021, Aldevron was acquired by Danaher for a cash purchase price of USD 9.6 billion.
Plasmid DNA Manufacturing Portfol
| S. No. | Parameters | Details |
| 1 | Type of Service(s) Offered |
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| 2 | Key Offerings |
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| 3 | Location of Manufacturing Facility |
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| 4 | Grade of Plasmid DNA |
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| 5 | Scale of Operation |
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| 6 | Application Area(s) |
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Recent Developments: In August 2023, Aldevron entered into a licensing agreement with Genentech (a subsidiary of Roche). As per the terms of the agreement, Genentech has been granted access to Aldevron's Nanoplasmid® vector technology for the production of novel therapies. With a compact backbone of less than 500 base pairs and the absence of bacterial encoding regions, the technology offers increased manufacturing yield, and improved safety profile.
In March 2023, the company also licensed two high yielding E. coli strains from Evanoa Bioscience to be used for plasmid manufacturing.
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AGC Biologics is focused on providing development and manufacturing services for antibodies, enzymes, plasmid DNA, mRNA, and other pharmaceutical ingredients using mammalian and microbial production systems. In addition, the company offers services for cell line development, bioprocess development, formulation, analytical testing, antibody drug development and conjugation, cell banking and storage and protein expression. AGC Biologics claims to comply with GMP guidelines for its development and manufacturing operations.
In June 2022, AGC Biologics was awarded Company of the Year in the Large - Manufacturing category at the 20th Annual American Business Awards®. Additionally, in the same year, the firm was recognized as one of the Top 10 Top Quality Assurance Services Companies in the pharmaceutical industry by Pharma Tech Outlook Europe.
Plasmid DNA Manufacturing Portfolio
| S. No. | Parameters | Details |
| 1 | Type of Service(s) Offered |
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| 2 | Key Offerings |
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| 3 | Location of Manufacturing Facility |
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| 4 | Grade of Plasmid DNA |
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| 5 | Scale of Operation |
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| 6 | Application Area(s) |
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Recent Developments: In June 2023, AGC Biologics announced the launch of AGCellerate, a program aimed at providing biopharmaceutical developers with cost-effective IND-ready GMP material, such as monoclonal antibodies (mAbs), lentiviral vectors, adeno-associated viral vector, and plasmid DNA. This program ensures fixed timelines and costs, thereby, expediting clinical stage advancements.
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Catalent is US-based CDMO engaged in providing development solutions, advanced delivery technologies and manufacturing services to pharma and biotech firms. Specific to plasmid DNA, their dedicated team of scientists and state-of-the-art facilities enable the development and manufacturing of high-quality plasmid DNA products. These services play a crucial role in cutting-edge research and the production of cell and gene therapy products, DNA vaccines, and other genetic medicines. As per the company website, Catalent Pharma Solutions has a strong focus on continued innovation and growth. Their future roadmap involves expanding their capabilities in advanced delivery technologies, such as targeted drug delivery systems and biologics manufacturing.
In 2021, the company acquired US based Delphi Genetics and Belgium based Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS) with the aim to expand its plasmid manufacturing operations.
Plasmid DNA Manufacturing Portfolio
| S. No. | Parameters | Details |
| 1 | Type of Service(s) Offered |
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| 2 | Key Offerings |
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| 3 | Location of Manufacturing Facility |
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| 4 | Grade of Plasmid DNA |
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| 5 | Scale of Operation |
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| 6 | Application Area(s) |
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Recent Developments: In January 2023, Catalent established a new EMA and the US FDA compliant commercial scale pDNA manufacturing facility, spanning 2,000 ft2 (1,100 m2) in Gosselies, Belgium. The facility is equipped with multiple cleanrooms, featuring 50 and 300 liter fermentation scales. Moreover, Catalent launched a new range of catalogued plasmids to offer support to cell and gene therapy developers.
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Centre for Breakthrough Medicines (CBM) claims to offers comprehensive manufacturing solutions for advanced therapy medicinal products, supporting clients from early-stage process development to clinical trials and commercialization. CBM specializes in manufacturing of viral vector products, crucial for delivering therapeutic genes to target cells, such as adeno-associated virus, lentivirus, adenovirus, and gamma retrovirus. In addition, the firm provides off-the-shelf plasmid DNA products to support the development of cell and gene therapy products across all scales of operation. The company claims to have no wait times for these plasmids, called Precision Plasmids™.2
In June 2022, CBM received a USD 350 million investment from SK pharmteco, which subsequently made SK pharmteco the second-largest shareholder of the company.
Plasmid DNA Manufacturing Portfolio
| S. No. | Parameters | Details |
| 1 | Type of Service(s) Offered |
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| 2 | Key Offerings |
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| 3 | Location of Manufacturing Facility |
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| 4 | Grade of Plasmid DNA |
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| 5 | Scale of Operation |
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| 6 | Application Area(s) |
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Recent Developments: In March 2023, Center for Breakthrough Medicines (CBM) and Cell One Partners, a cell and gene therapy consulting company, formed an alliance to offer efficient end-to-end gene therapy services, including nucleic acid synthesis and plasmid production. Jennifer Manning, SVP of Global Strategic Partnerships at CBM, stated, “The missions of our two organizations are aligned – to advance cell and gene therapy research from idealization to commercialization in an effort to save lives.”
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With over 75 years of experience, Charles River provides comprehensive range of services to pharma and biotech companies, government agencies, hospitals and academic institutions, worldwide. The primary focus of the company is on providing basic research, drug discovery and development services, conducting safety and efficacy studies, and providing clinical support and manufacturing services across a wide range of therapeutic areas. With state-of-the art manufacturing facility, Charles River offers plasmid production services as part of its cell and gene therapy CDMO solution. The company utilizes its proprietary eXpDNA™ technology and expertise to produce high-quality plasmid DNA at various scales, catering to preclinical, clinical, and commercial requirements. Additionally, Charles River offers customizable plasmid and viral vector products in order to facilitate gene therapy discovery and research programs. In 2021, Charles River expanded its comprehensive portfolio of viral vector, plasmid DNA, and cell therapy production services, through the acquisitions of Cobra Biologics, Cognate BioServices, and Vigene Biosciences.
Plasmid DNA Manufacturing Portfolio
| S. No. | Parameters | Details |
| 1 | Type of Service(s) Offered |
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| 2 | Key Offerings |
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| 3 | Location of Manufacturing Facility |
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| 4 | Grade of Plasmid DNA |
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| 5 | Scale of Operation |
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| 6 | Application Area(s) |
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Recent Developments: In September 2023, Chares River signed an agreement with INADcure Foundation to provide high quality (HQ) plasmid DNA for the development of latter’s lead therapeutic candidate intended for the treatment of infantile neuroaxonal dystrophy (INAD). This collaboration aims to address the critical supply shortage of plasmid DNA, a vital component for cell and gene therapy products, and accelerate the timeline to clinic.
In March 2022, the company also announced expansion plans at its Cheshire, UK facility focused on HQ plasmid production. The facility was opened in June 2022.3
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GenScript ProBio, a subsidiary of GenScript, specializes in providing comprehensive range of services for the development and commercialization of biologics. These services include cell line development, process development, and cGMP manufacturing of monoclonal antibodies, recombinant proteins, and cell and gene therapy products. Furthermore, the firm employs advanced technologies for the production of reliable and scalable plasmid DNA for gene therapy applications, DNA vaccines, and other genetic medicine research. By leveraging its advanced technologies and automation, and strengthening their research and development efforts, GenScript ProBio aims to meet the increasing demand for biologics and contribute to the development of innovative therapies.
The company opened its GMP plasmid manufacturing facility in Zhenjiang, Jiangsu Province in December 2021. This was followed by announcement to expand the facility, breaking ground on construction in January 2022.4
Plasmid DNA Manufacturing Portfolio
| S. No. | Parameters | Details |
| 1 | Type of Service(s) Offered |
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| 2 | Key Offerings |
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| 3 | Location of Manufacturing Facility |
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| 4 | Grade of Plasmid DNA |
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| 5 | Scale of Operation |
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| 6 | Application Area(s) |
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Recent Developments: In June 2023, GenScript ProBio and Comprehensive Cell Solutions partnered to offer integrated cell therapy solution. The partnership aims to accelerate the delivery of innovative treatments to patients in need by leveraging GenScript ProBio's expertise in gene therapy development (such as viral vector and plasmid production) and CCS's proficiency in clinical cell therapy manufacturing and bone marrow transplant services.
In February 2023, GenScript ProBio announced an agreement with Singapore based RVAC Medicines to provide GMP plasmid manufacturing services for the latter’s clinical stage mRNA COVID vaccine.
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PackGene Biotech is a US-based CRO / CDMO that claims to offer reliable, scalable, and cost-effective plasmid DNA and adeno-associated viral vector production services. With a comprehensive pDNA manufacturing portfolio, PackGene supports vector design and cloning, including plasmid extraction, transfection application, and GMP mRNA and lipid nanoparticle manufacturing. Moreover, as per the company website, the firm employs its proprietary π-OmegaTM Platform, which leverages plasmid backbone modifications to achieve more than three-fold increase in plasmid yield. By optimizing plasmid DNA production, PackGene aims to empower organizations to enhance their research and development efforts in the field of cell and gene therapy.
Plasmid DNA Manufacturing Portfolio
| S. No. | Parameters | Details |
| 1 | Type of Service(s) Offered |
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| 2 | Key Offerings |
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| 3 | Location of Manufacturing Facility |
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| 4 | Grade of Plasmid DNA |
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| 5 | Scale of Operation |
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| 6 | Application Area(s) |
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Recent Developments: In February 2023, PackGene Biotech expanded its services with addition of a new GMP biomanufacturing and processing facility in Houston, Texas. The 25,000 ft2 facility supports gene therapy programs and provides economical, reliable, and scalable AAV products. As part of its expansion efforts, PackGene Biotech aims to position itself as a comprehensive one-stop-shop solution provider for gene therapy developers.
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Thermo Fisher Scientific is a global service provider in the pharmaceutical development and manufacturing domain. With a vast network of more than 60 facilities, its service portfolio spans throughout the development process, including API discovery, formulation development, analytical testing, as well as clinical and commercial manufacturing. In addition, Thermo Fisher Scientific leverages its extensive experience in biomanufacturing to provide reliable and efficient plasmid and viral vector production services. As per the company website, the firm has obtained certifications and approvals from major regulatory agencies worldwide, including the USFDA, the EMA, and the PMDA.
Plasmid DNA Manufacturing Portfolio
| S. No. | Parameters | Details |
| 1 | Type of Service(s) Offered |
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| 2 | Key Offerings |
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| 3 | Location of Manufacturing Facility |
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| 4 | Grade of Plasmid DNA |
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| 5 | Scale of Operation |
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| 6 | Application Area(s) |
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Recent Developments: In July 2021, Thermo Fisher Scientific established a new 67,000 ft2 GMP plasmid manufacturing facility in Carlsbad, California. This strategic move aims to meet the increasing demand for plasmid DNA-based therapeutics and mRNA vaccines.
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VGXI is a CDMO specializing in the development and production of DNA-based vaccines and gene therapy products. The firm claims to provide end-to-end services, from DNA vector design and process development to vector production and regulatory support. The plasmid DNA services offered by the firm cater to a broad range of requirements, from early-stage research to large-scale commercial production, ensuring the delivery of high-quality products that meet regulatory standards. Over the years, VGXI has manufactured over 175 batches of plasmid DNA, making significant contributions to the advancement of ATMP clinical trials conducted around the globe.
Plasmid DNA Manufacturing Portfolio
| S. No. | Parameters | Details |
| 1 | Type of Service(s) Offered |
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| 2 | Key Offerings |
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| 3 | Location of Manufacturing Facility |
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| 4 | Grade of Plasmid DNA |
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| 5 | Scale of Operation |
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| 6 | Application Area(s) |
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Recent Developments: In October 2022, VGXI inaugurated its new headquarters and manufacturing facility in Conroe, Texas. The 120,000 ft2 purpose-built facility has four distinct manufacturing suites and flexible fermentation capacity up to 3,000 liter. This expansion allows VGXI to support small-scale through commercial plasmid DNA and RNA supply for clients worldwide.
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WuXi ATU, a subsidiary of WuXi AppTec, is a CTDMO engaged in offering comprehensive suite of platform for the development, testing, manufacturing, and commercialization of cell therapies, gene therapy products, and other advanced biopharmaceuticals. In addition, the organization claims to offer a range of integrated services to expedite the time-to-market and facilitate drug development programs, globally. Moreover, in January 2022, Wuxi ATU completed a successful remote inspection by the European Medicines Agency (EMA) for its advanced therapies testing facility in Philadelphia. In addition, the firm received official confirmation regarding the issuance of a GMP certificate. Furthermore, in March 2022, the company launched Tetracycline-Enabled Self-Silencing Adenovirus (TESSATM) technology for manufacturing transfection-free, GMP grade AAV.
Plasmid DNA Manufacturing Portfolio
| S. No. | Parameters | Details |
| 1 | Type of Service(s) Offered |
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| 2 | Key Offerings |
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| 3 | Location of Manufacturing Facility |
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| 4 | Grade of Plasmid DNA |
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| 5 | Scale of Operation |
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| 6 | Application Area(s) |
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Recent Development: With the expertise of WuXi ATU, TICAROS achieved a significant milestone in March 2023 by obtaining Clinical Phase I/II IND approval from the Korean Ministry of Food and Drug Safety (MSFD) for its cell therapy product. This milestone marks a significant step forward in advancing cutting-edge therapies for patients in need.
In May 2023, Interius BioTherapeutics announced their manufacturing partnership with WuXi ATU to leverage their plasmid manufacturing and vector manufacturing expertise, for advancing its lead program, a CAR T cell therapy into clinical trials.
The above presentation features ten promising players from a pool of around 65 plasmid manufacturers 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.
Jayita is a Senior Business Analyst who has been a valuable member of the Roots Analysis team since 2021. She holds a bachelor's degree in pharmacy from a prestigious institute, which has provided her with a strong academic background. With her commitment for staying at the forefront of the healthcare and life sciences domain, she can effectively analyze complex data and provide actionable insights.
Throughout her career, Jayita has contributed to over six syndicate market research reports, covering a wide range of trending domains. Some of the areas she has worked on include protein design and engineering, metabolomics services, bioavailability enhancement technologies and services, plasmid DNA manufacturing, and NAMPT inhibitors. In addition to her expertise in market research, Jayita has also demonstrated her financial acumen through her involvement in an investor series project focused on the intriguing field of RNA therapeutics. This project highlights her ability to navigate the complex intersection of science and finance.
Email: jayita.sood@rootsanalysis.org
LinkedIn: https://www.linkedin.com/in/jayita-sood-6b7742113
Source 1: https://investors.modernatx.com/news/news-details/2021/Moderna-and-Aldevron-Announce-Expanded-Partnership-for-mRNA-Vaccine-and-Therapeutic-Pipeline/default.aspx
Source 2: https://www.contractpharma.com/contents/view_breaking-news/2023-02-07/center-for-breakthrough-medicines-launches-precision-plasmids-manufacturing/
Source 3: https://seekingalpha.com/news/3852384-charles-river-laboratories-opens-manufacturing-facility-in-cheshire-uk
Source 4: https://www.genscriptprobio.com/successful-groundbreaking-ceremony-for-genscript-probio-to-expand-commercial-cgmp-plasmid-and-viral-vector-manufacturing-facility-in-zhenjiang-china.html
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