VGXI, Inc.

CONROE, Texas, March 27, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, is pleased to announce the appointment of Stephanie Burke as the Chief Accounting Officer (CAO) for VGXI. Ms. Burke joined the company in 2015 bringing with her over a decade of accounting and leadership expertise and has since played an instrumental role in the company's financial operations. Ms. Burke has previously held leadership roles overseeing both the VGXI Accounting/Finance and Materials teams. Her expertise was essential to guide VGXI through the successful implementation of MISys, the company's electronic MRP system, to streamline manufacturing operations and enhance efficiency. "I am honored to take on the position of Chief Accounting Officer," said Ms. Burke. "I look forward to working with our talented team in my new role to drive financial excellence to support VGXI's future growth initiatives in the years to come." Prior to VGXI, Ms. Burke served as the Financial Controller at Manuli RYCO / Fliuconnecto, a global manufacturer and distributor of hydraulic products and was the General Manager of International Expo Service, an exhibit builder and service company for trade shows, overseeing operations. Ms. Burke received her Bachelor of Business Administration in Accounting from Washington State University. "Stephanie has been an invaluable member of the VGXI team since 2015. Her exceptional financial acumen coupled with her leadership skills make her the ideal candidate for the Chief Accounting Officer position. This well-deserved promotion recognizes the significant contributions Stephanie has made to VGXI during her tenure and she will undoubtedly play a critical role in shaping our financial strategies as we enter our next phase," said VGXI's CEO, Young Park. ABOUT VGXI, INC. With over 20 years of experience VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI's ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and highly experienced development team. VGXI, Inc. is a GeneOne company. To learn more, visit . ABOUT GENEONE LIFE SCIENCE GeneOne Life Science Inc. ("GeneOne" KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II). For more information, visit . Contact: Justin Smith, Director of Marketing [email protected] SOURCE VGXI, Inc.

The U.S. plasmid DNA contract manufacturing market size is expected to surpass around USD 849.23 million by 2033 and growing at a CAGR of 19.25% from 2024 to 2033. The market size of plasmid DNA contract manufacturing in the United States was estimated at USD 146.03 million in 2023. The U.S. plasmid DNA contract manufacturing market is driven by the increasing demand for plasmid DNA in various biotechnological applications. The U.S. plasmid DNA contract manufacturing market has witnessed significant growth in recent years, driven by the increasing demand for plasmid DNA in various biotechnological applications. This overview delves into the key factors shaping the market landscape, exploring market trends, major players, and future prospects. Key Pointers By Application, the cell and gene therapy segment held the largest revenue share of 61% in 2023. By Application, the immunotherapy segment is anticipated to experience substantial growth from 2024 to 2033. By Therapeutic Area, the cancer segment generated the maximum market share of 40% in 2023. By End-use, the pharmaceutical and biotechnology companies contributed the largest market share of 60% in 2023. By End-use, the research institutes segment is expected to expand at the highest CAGR from 2024 to 2033. Get Sample Copy of Report@ U.S. Plasmid DNA Contract Manufacturing Market Growth The growth of the U.S. plasmid DNA contract manufacturing market can be attributed to several key factors. Firstly, the increasing demand for plasmid DNA in the biopharmaceutical industry for the production of therapeutic proteins and vaccines plays a pivotal role. The expanding applications of gene therapies and personalized medicine further fuel the demand for plasmid DNA manufacturing services. Additionally, advancements in genetic engineering technologies and the rise of innovative therapeutic modalities contribute to market growth. Collaborations between pharmaceutical companies and contract manufacturers also foster the market, allowing for cost-effective and efficient production processes. Furthermore, the growing investment in research and development activities within the biotechnology sector amplifies the need for outsourced plasmid DNA manufacturing services, driving sustained market expansion. Full Report is Ready, Get Access@ Plasmid DNA contract manufacturing plays a vital role in the United States for several reasons: Biopharmaceutical Development: Plasmid DNA serves as a crucial component in the development of biopharmaceuticals, including vaccines, gene therapies, and biologics. Contract manufacturing organizations (CMOs) specializing in plasmid DNA production provide the necessary expertise and infrastructure to support the biopharmaceutical industry's needs. Scalability: CMOs offer scalable production capabilities, allowing biotech and pharmaceutical companies to manufacture plasmid DNA at various scales, from preclinical to commercial quantities. This scalability is essential for accommodating the diverse needs of different drug development stages. Regulatory Compliance: Plasmid DNA manufacturing for pharmaceutical use must adhere to stringent regulatory standards set by agencies like the FDA. Contract manufacturers specialize in ensuring compliance with these regulations, offering expertise in current Good Manufacturing Practices (cGMP) to meet quality and safety requirements. Cost-Efficiency: Outsourcing plasmid DNA manufacturing to specialized CMOs can often be more cost-effective than establishing in-house production facilities. CMOs benefit from economies of scale, specialized equipment, and streamlined processes, reducing overall production costs for pharmaceutical companies. Flexibility and Expertise: CMOs bring a high level of flexibility and expertise to plasmid DNA manufacturing. They can adapt to changing project requirements, offer technical support, and employ skilled personnel with experience in molecular biology, cell culture, and bioprocess engineering. Accelerated Timelines: Partnering with CMOs for plasmid DNA manufacturing can accelerate drug development timelines. These organizations are equipped to efficiently execute production processes, enabling faster turnaround times for delivering critical materials to support clinical trials and commercialization efforts. Risk Mitigation: Outsourcing plasmid DNA manufacturing can help mitigate risks associated with production, such as equipment maintenance, process optimization, and regulatory compliance. CMOs assume responsibility for these aspects, allowing pharmaceutical companies to focus on core research and development activities. Global Competitiveness: Access to reliable plasmid DNA contract manufacturing services enhances the global competitiveness of the U.S. biopharmaceutical industry. By leveraging the expertise and infrastructure of CMOs, American companies can remain at the forefront of innovation and drug development in an increasingly competitive market. Supportive Ecosystem: The U.S. provides a supportive ecosystem for biopharmaceutical manufacturing, with government incentives, tax breaks, and grants available to encourage investment and expansion. This supportive environment fosters the growth of plasmid DNA contract manufacturing and strengthens the overall biopharmaceutical industry. U.S. Plasmid DNA Contract Manufacturing Market Trends Rising Demand for Gene Therapies: The market is witnessing a surge in demand driven by the increasing prominence of gene therapies. Plasmid DNA serves as a crucial component in the development of these innovative therapeutic approaches, propelling the contract manufacturing sector. Advancements in Genetic Engineering Technologies: Continuous advancements in genetic engineering technologies contribute to the market's growth. The adoption of cutting-edge techniques enhances the efficiency and scalability of plasmid DNA manufacturing processes, meeting the evolving needs of the biopharmaceutical industry. Expanding Applications in Biopharmaceuticals: Plasmid DNA finds extensive applications in the production of therapeutic proteins and vaccines within the biopharmaceutical sector. This diversification of applications increases the market's significance, with contract manufacturing services playing a pivotal role in meeting the industry's production demands. Increasing Embrace of Personalized Medicine: The trend towards personalized medicine amplifies the demand for plasmid DNA, as it is integral to the development of tailored therapeutic solutions. Contract manufacturers play a key role in facilitating the production of personalized treatments, contributing to market expansion. Growing Research and Development Investments: The biotechnology sector's increasing investment in research and development activities positively influences the U.S. plasmid DNA contract manufacturing market. As companies focus on developing novel therapies, the demand for outsourced manufacturing services continues to grow, fostering market expansion. Application Insights In 2023, the cell and gene therapy segment secured the largest market share at 61%, establishing its dominance and poised for continued growth. This trend is primarily fueled by a surge in clinical trials and subsequent drug approvals within the field. The market's expansion is underpinned by the increasing trust, efficiency, and safety of gene treatments, addressing a spectrum of chronic and genetic disorders. The involvement of Contract Development and Manufacturing Organizations (CDMOs) in the development of new plasmid DNA significantly contributes to market growth. A notable example is the collaboration between Ray Therapeutics and Forge Biologics, a CDMO. Their extended partnership in October 2022 focuses on manufacturing clinical-stage plasmid DNA to support Ray Therapeutics' lead optogenetics gene therapy program. Looking ahead, the immunotherapy segment is anticipated to experience substantial growth from 2024 to 2033. This growth is propelled by heightened research and development activities in the realm of immunotherapy. Given the high prevalence of cancer, the adoption rates for novel immunotherapies have soared. A JAMA Oncology report from 2023 reveals adoption rates of approximately 11% and 27% in rural and urban clinical practices in the U.S., respectively. This prevalence is expected to drive the growth of the immunotherapy segment in the forecast years. Therapeutic insights In 2023, the cancer segment emerged as the dominant force in this market, claiming a substantial 40% share. This growth is primarily fueled by the escalating prevalence of cancer and the intensified focus of key industry players on cancer therapeutics. The increasing adoption of cell and gene therapy for cancer treatment is a key driver propelling the expansion of the U.S. plasmid DNA contract manufacturing market. A noteworthy example is Charles River's collaboration with Rznomics, announced in October 2023, to manufacture viral vectors for gene therapy targeting patients with liver cancer. Anticipated to exhibit the fastest growth rate from 2024 to 2033, the infectious segment is propelled by the growing commercialization of plasmid DNA therapeutics for treating infectious diseases. For instance, the collaboration between GeneScript ProBio and RVAC in February 2023 aimed to manufacture a COVID-19 Vaccine plasmid DNA. This partnership seeks to accelerate the clinical manufacturing of RVM-V001 and future mRNA-based vaccines addressing infectious diseases such as Clostridioides difficile infection (CDI) and Respiratory Syncytial Virus (RSV). End-use Insights In 2023, the pharmaceutical and biotechnology companies held a commanding share of 60%, asserting their dominance in the market. This growth is attributed to the escalating production of plasmid DNA-based therapeutics throughout the U.S. Key market players are actively engaging in strategic initiatives to enhance plasmid DNA production, contributing significantly to the segment's expansion. A notable example is Charles River Laboratories International, Inc., which, in January 2023, announced the launch of the eXpDNA™ plasmid platform. This innovative platform aims to streamline plasmid manufacturing and production timelines, particularly in the context of gene therapy. The research institutes segment is poised for the fastest growth from 2024 to 2033, fueled by increasing funding for cell and gene therapy-based research. Research institutes play a crucial role in advancing the research and development of cell and gene therapies, responding to the growing demand for plasmid DNA. The combination of augmented funding and the rising demand for plasmid DNA-based therapeutics is set to propel robust growth in this segment within the plasmid DNA contract manufacturing market. As an example, in September 2019, the National Institutes of Health (NIH) disclosed the allocation of 24 grants to researchers across the United States through the Somatic Cell Genome Editing (SCGE) Program. Funded by the NIH Common Fund, this program aims to enhance genome-editing techniques and the manufacturing of genome-editing therapies. U.S. Plasmid DNA Contract Manufacturing Market Key Companies Aldevron Charles River Laboratories Akron Biotech VGXI, Inc. Catalent, Inc DH Life Sciences, LLC Recipharm AB TriLink BioTechnologies AGC Biologics Thermo Fisher Scientific Inc. Recent Developments In February 2023, PackGene Biotech announced the expansion of its services with the addition of a new GMP biomanufacturing and processing facility in Houston, Texas. This consists of gene therapy programs and provides economical, reliable, and scalable AAV products. Through this expansion, the company aims to become a one-stop-shop solution provider for gene therapy developers. In January 2023, Catalent announced the new EMA and US FDA-approved pDNA manufacturing facility in Belgium. Through this, Catalent launched a new range of cataloged plasmids to offer support to cell and gene therapy developers. U.S. Plasmid DNA Contract Manufacturing Market Segmentations: By Application Cell & gene therapy Immunotherapy Other application By Therapeutic Area Cancer Infectious Diseases Autoimmune Diseases Cardiovascular Diseases Others By End-use Pharmaceutical and Biotechnology Companies Research Institutes Full Report is Ready, Get Access@ USA - +1 650 460 3308 | IND - +91 93077 85324 OR sales@visionresearchreports.com

CONROE, Texas, March 4, 2024 /PRNewswire/ -- VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, proudly announces the appointment of Michael Stewart as its new Chief Operating Officer (COO). Stewart brings over 20 years of extensive experience in the viral vector therapy and vaccine production industry, which will be instrumental to VGXI's continued growth and success. Prior to joining VGXI's leadership team, Stewart served as COO at Matica Biotechnology, Inc., a CDMO providing manufacturing services for cell and gene therapy products, where he led technical functions including GMP manufacturing, supply chain, facilities and engineering, automation engineering, external project management, process engineering, process development, and assay development. He also previously held leadership roles at leading research and manufacturing organizations including Fujifilm Diosynth Biotechnologies, Boehringer-Ingelheim Biomanufacturing, Meridian Life Science, and St. Jude's Children's Research Hospital. "We are thrilled to welcome Michael Stewart to VGXI as our new Chief Operating Officer," said VGXI's CEO, Young Park. "His wealth of CDMO experience and proven track record will be pivotal in our commitment to providing top-tier DNA plasmid manufacturing services to the global biopharmaceutical community. We look forward to the positive impact he will have on our business and our clients. We also deeply appreciate all the years of service that Dorothy Peterson dedicated to VGXI and wish her all the best in her retirement." Stewart holds a B.S. and M.S. degrees in chemistry and biochemistry from the Texas A&M University System, followed by a Ph.D. studies in biochemistry at the University of Tennessee and St. Jude Children's Research Hospital, focusing on the structural and functional amino acid substitutions that result in an oncogenic state. Additionally, Stewart has a distinguished military background, having served as a medical corpsman with the U.S. Navy/Marine Corps and contributing to DOD research related to gravitationally induced loss of consciousness. Stewart's appointment follows the retirement of Dorothy Peterson, VGXI's former COO, who dedicated 16 years of service to the company – first as the Director of Quality, then Vice President of Operations and finally as COO. Ms. Peterson's contributions over the years have been invaluable, and VGXI extends its heartfelt appreciation for her commitment and leadership throughout her tenure. Please join VGXI in extending a warm welcome to Michael Stewart as he assumes his new role as Chief Operating Officer, effective immediately. ABOUT VGXI, INC. With over 20 years of experience VGXI, Inc. is a leading provider of plasmid DNA manufacturing and development services. The company has a reputation of success in manufacturing DNA products under cGMP conditions for clinical trials in the US, EU, Asia, Canada, and Australia, and its cGMP and non-GMP products have passed rigorous reviews by several international regulatory agencies. VGXI's ability to work with unique requirements and create custom manufacturing solutions is based on its patented manufacturing process, flexible cGMP production facility, and highly experienced development team. VGXI, Inc. is a GeneOne company. To learn more, visit . ABOUT GENEONE LIFE SCIENCE GeneOne Life Science Inc. ("GeneOne" KOSPI: 011000) headquartered in Seoul, South Korea is an international biotechnology company and a leading contract manufacturer of DNA plasmids for use in vaccines, gene therapies, and cell therapies. GeneOne has recently expanded into the manufacture and development of mRNA. GeneOne has maintained a focus on vaccines against emerging infectious diseases to address global needs, including in resource challenged regions. Its small molecule portfolio of immunomodulators address diseases such as prevention of upper respiratory bacterial and viral diseases, and treatment of autoimmune and inflammatory diseases. GeneOne has three products against COVID-19 in clinical development: GLS-5310 DNA vaccine (Phase I/IIa), GLS-1200 nasal spray to prevent COVID-19 infection (Phase II), and GLS-1027 to prevent the inflammation and clinical worsening for those infected with COVID-19 (Phase II). For more information, visit . Contact: Justin Smith, Director of Marketing [email protected] SOURCE VGXI, Inc.