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Introduction: INOVIO plans to produce 100 million doses of the new coronary pneumonia candidate vaccine INO-4800 by 2021.
8, 2020, INOVIO announced that Thermo Fisher Science, a global leader in scientific services, has signed a letter of intent to produce INOVIO's new crown pneumonia DNA candidate vaccine, INO-4800.
Technology joined other contract development and manufacturing organizations of the INOVIO Global Manufacturing Alliance, enabling INOVIO to be expected to carry out large-scale commercial production of the INO-4800.
with a coalition of third-party manufacturers, INOVIO plans to produce 100 million doses of the INO-4800 vaccine by 2021, but this will require FDA approval of the INO-4800 as the new coronary pneumonia vaccine.
Technology plans to produce INO-4800 API and to fill and follow-up processes for INO-4800 pharmaceuticals at its U.S. commercial manufacturing facilities.
Technology estimates that at full production, the company can produce at least 100 million doses of INO-4800 per year.
president and chief executive officer of INOVIO. Dr Joseph Kim said: "INOVIO welcomes Thermo Technology to our global alliance of large-scale commercial vaccine manufacturers, and we look forward to working with them to accomplish this significant work.
capabilities and scale of Technology will be key to our production progress.
the urgent need for a safe and effective new coronary pneumonia vaccine around the world, Thermo Technology's commitment to high-quality and reliable production will be key to meeting this demand.
" Leon Wyszkowski, President of Commercial Operations for Thermo's Pharmaceutical Services business, said, "INOVIO has truly recognized the value of our end-to-end capabilities -- from the initial work of our clinical trials to supporting their current business needs.
we will continue to fully support INOVIO's plan to produce 100 million doses of vaccine by 2021.
. J. Juba Jr., Vice President of Bioman manufacturing and clinical supply management at INOVIO, said, "INOVIO is pleased to be working with Thermo Technology to produce DNA granules and pharmaceuticals.
Technology provides end-to-end solutions for production, labeling, packaging and distribution, which we believe will help us deliver hundreds of millions of doses of the INO-4800 vaccine to the United States and the rest of the world.
" Technology will join existing partners Richter-Helm BioLogics and Ology Biosciences as new members of the INOVIO Global Manufacturing Alliance.
INOVIO is actively discussing joining the alliance with more manufacturers in the hope of reaching more manufacturing cooperation and expanding the alliance to meet global supply needs.
involve multiple manufacturers in the production of the INO-4800, with the aim of producing this DNA vaccine in a cost-effective and scalable manner in a timely manner.
third-party manufacturers of INOVIO will produce patented INO-4800 vaccine preparations to enhance vaccine stability and good tolerance.
important is that the INO-4800 has good thermal stability.
other platform DNA candidate vaccines called INOVIO have a shelf life of more than 5 years when refrigerated, more than 30 days at 37 degrees Celsius, and more than 1 year at room temperature.
drug candidates for INOVIO do not need to be refrigerated during transport or storage, which is an important factor in global immunization.
the INO-4800 is delivered via INOVIO's proprietary CELLELCTRA® smart delivery device, which delivers the vaccine partially into the patient's skin in just a few seconds.
INOVIO is conducting phase I clinical trials of INO-4800 in the United States and has submitted the full results of the first 40 subjects for publication in peer-reviewed journals.
the company plans to launch a two-thirds trial of the new coronary pneumonia vaccine in September, subject to FDA approval.
earlier this summer, INOVIO received $71 million from the U.S. Department of Defense to support the large-scale production of the company's CELLECCTRA®3PSP proprietary equipment and the procurement of CELLECTRA®2000 equipment.
received $5 million from the Bill and Melinda Gates Foundation and the Alliance for Epidemiological Prevention and Innovation (CEPI) to speed up the testing of CELLECCTRA®3PSP, respectively, before it received funding from the Department of Defense.
development of the next-generation CELLECCTRA®3PSP smart device began in 2019 with $8.1 million from Medical CBRN Defense Consortium, the medical arm of the U.S. Defense Threat Reduction Agency.
INOVIO Global Alliance to Advance INO-4800 Profile INOVIO has formed a global alliance of partners, partners and funders to rapidly advance the INO-4800 development.
, research and development partners include the Westa Institute, the University of Pennsylvania, the University of Texas, Fudan University and Laval University.
INOVIO has been working with Ai Weixin and the International Vaccine Institute to advance clinical trials of the INO-4800 in China and South Korea, respectively.
INOVIO also worked with Public Health England and the Commonwealth Scientific and Industrial Research Organization of Australia to assess the preclinical effects of INO-4800 in several animal challenge models.
INOVIO has also partnered with a number of contract manufacturers such as Seymru Technology, Richter-Helm BioLogics and Ology Biosciences to commercialize the INO-4800 and is seeking additional external funding and partners to expand production capacity to meet the global demand for safe and effective vaccines.
, the Alliance for Epidemiological Prevention and Innovation, the Bill and Melinda Gates Foundation, and the U.S. Department of Defense have provided significant funding for the development and production of the INO-4800.
INO-4800 Introduction INO-4800 is an INOVIO DNA candidate vaccine for the prevention of new coronavirus.
INOVIO has extensive experience in developing coronavirus vaccines and is the only company with MERS coronavirus vaccines in Phase 2 trials.
INOVIO's DNA Drug Platform Profile INOVIO is currently developing 15 clinical projects for DNA drugs focusing on human papillomavirus (HPV)-related diseases, cancers and infectious diseases, including the Development of the Alliance for Innovation in Epidemiological Prevention (CEPI) and the U.S. Department of Defense-funded MERS coronavirus and new coronavirus vaccines.
drug consists of optimized prosurge DNA, a small molecular ring-shaped double-stranded DNA that is synthesized or recombined using computer sequencing techniques to produce a specific immune response in the body.
INOVIO's DNA drug uses CELLECCTRA®, the company's proprietary handheld smart device, to deliver optimized particles directly to cells from within the muscle or skin.
easy-to-use CELLECTRA device uses a short electrical pulse to reverse-open small holes in cells in the local skin area, increasing product delivery by more than 100 times, reducing dose and achieving uniformity.
once it enters the cell, the cell can use the granule DNA to produce target antigens.
the antigens are processed naturally within the cell, triggering the required T-cell and antibody-mediated immune response.
using CELLECTRA devices for administration takes only a few seconds to ensure that DNA drugs are effectively delivered directly to human cells, thus playing a role in driving the immune response.
INOVIO's DNA drugs are transient and do not interfere with or alter an individual's own DNA in any way.
advantage of INOVIO's DNA drug platform is its ability to design and produce DNA drugs quickly.
drug is stable, does not need to be refrigerated during storage and transport, and has been clinically proven to continuously stimulate the body to produce an immune response, with safety and tolerance.
more than 7,000 applications in a series of clinical trials, more than 2,000 patients received INOVIO's research DNA drug.
INOVIO is committed to rapidly developing DNA candidate drugs that can help the global response to emergency health events.
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