MEDTECH

Seegene Develops World's First COVID-19 Diagnostic Variant Test Capable of Identifying Multiple Mutant Variations

Seegene | February 01, 2021

South Korea's biotechnology firm Seegene (KQ096530) said Monday it built up the world's first COVID-19 diagnostic variation test, fit for screening COVID-19 and recognizing various mutant variations in a single reaction.

Seegene's new variation test, the 'Allplex™ SARS-CoV-2 Variants I Assay,' can detect  and separate virus variations, including those discovered to be more contagious and fatal.

The new variation test identifies COVID-19, yet can likewise recognize major genetic variations that appear to have originated from the UK, South Africa just as different districts including Japan and Brazil.

Besides, it can pre-screen a suspicious new variant, giving understanding on extra variations, likewise a critical component of Seegene technology.

Seegene's new item incorporates in any event ten of its proprietary technologies, including multiplex real-time PCR technique for mTOCE™, which is the forefront technology that solitary Seegene can use. This imaginative technology permits the test to distinguish an objective explicit spot where mutation occurs, empowering exact detection and separation of the Covid just as its transformed versions with a single tube of reagent.

Spotlight

Cells are the basic building blocks of all living things. The command center of each cell is called the nucleus, and it contains chromosomes. Chromosomes are made up of DNA the body’s hereditary material.Typically, every person has 2 copies of each gene one from each parent.A person has about 20,000 genes, and most are the same in all people. However, each person has a small number of genes that are slightly different. These slight differences in genes are why people have different features.

Spotlight

Cells are the basic building blocks of all living things. The command center of each cell is called the nucleus, and it contains chromosomes. Chromosomes are made up of DNA the body’s hereditary material.Typically, every person has 2 copies of each gene one from each parent.A person has about 20,000 genes, and most are the same in all people. However, each person has a small number of genes that are slightly different. These slight differences in genes are why people have different features.

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MEDTECH

Tavotek Biotherapeutics Announces Completion of Round B Financing with $35 Million

Tavotek | November 19, 2021

Tavotek Biotherapeutics, a fast-growing biotech company, announces it has raised $35M in Round B financing. CS Capital, a leading private equity fund manager in China, led this finance round followed by Fontus Capital. This round of financing will be used to accelerate the Phase 1 clinical development of several antibody drugs to start in early 2022. The upcoming antibody drugs were developed by the company based on its TavoPrecise antibody platform for various immune-related disorders. In addition, the funding will also be used to accelerate the CMC and IND development of multiple other oncology pipelines and the development of the company's multicyclic intracellular peptide (MIP) programs. Tavotek Biotherapeutics, established in early 2019, is committed to using innovation to improve the well-being of patients with unmet medical needs. The company has two R&D centers: one in Lower Gwynedd, Pennsylvania and another in Suzhou, China. The core team members have decades of successful drug development experiences at multinational pharmaceutical firms (Johnson & Johnson, Abbott/Abbvie, GlaxoSmithKline and Eli Lilly) which include many blockbuster drugs with annual sales of more than $1 billion. Tavotek's research platforms are built upon three breakthrough technologies: TavoSelect (an innovative Phage Display Library that generates conformational selective human full-length and single domain antibodies); TavoPrecise (a differentiated engineering platform for next generation tissue-specific biologics); and TavoMIP (a multicyclic peptide platform that makes undruggable targets more accessible). With the new infusion of capital, Tavotek is developing novel biologics targeting oncology and autoimmune diseases for patients. The company plans to bring multiple innovative antibodies into human clinical trials in 2022. About Tavotek Tavotek is a biopharmaceutical company focused on discovering, acquiring, developing, and commercializing medicines for patients suffering from debilitating diseases with significant unmet medical needs. Tavotek has a rich pipeline of product candidates at various stages of development for cancer, autoimmune conditions, and inflammatory diseases.

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DIAGNOSTICS

Provectus Algae Expands into New Large-Scale Microalgae Biomanufacturing Facility

Provectus Algae | August 28, 2021

Provectus Algae, an Australian biotechnology platform company specialising in the biomanufacturing of high-value compounds for a wide array of industries using microalgae, announced they will be expanding into an additional large-scale manufacturing facility. “Since closing our seed round last year, we have been in full swing growing the team, developing products and building capacity with our proprietary production system. We are now in a strong position as we push into this next phase of the company's growth” Located in Noosaville, Australia, the new site is expected to be operational by the end of 2021 and will complement the company’s existing facility to deliver new algae-made products to the market. The new facility will support the production of a high-performance food colouring which is currently in late stage of development. Once completed, the facility will have a 200,000 litre production capacity and expanded R&D operations to support early-stage product development and partnerships for the Food & Beverage sector. Provectus’s inaugural pilot facility will subsequently be converted to support the commercial production of a separate high-value product that is currently undergoing product testing. The company expects further expansion in the near term with plans for a supplementary 1 million litre facility already underway to support the commercialisation of multiple products already in the company development pipeline. Provectus has engaged global food & beverage companies to craft a tailored development pipeline of products most relevant to the strengths of the company’s biomanufacturing platform. The flexibility of the company’s unique platform approach is evidenced by the speed at which lead products have moved through the development pipeline to commercial readiness. “This is just the tip of the iceberg for Provectus Algae. The stage of development we are now at with our production platform gives us a clear line of sight to deliver some really exciting products to the food and beverage marketplace,” said Nusqe Spanton, Founder and CEO of Provectus Algae. “What we are able to achieve for our commercial partners is simply not comparable to any other offering in the marketplace. Thanks to algae, we are able to benefit from a 3.5-billion-year head start in producing some of the world’s most coveted ingredients.” The Provectus platform addresses supply chain challenges by providing end-to-end services from product development to large-scale biomanufacturing. Importantly, the manufacturing platform is able to go from bench to industrial-scale seamlessly with a continuity of their novel production technology. “Since closing our seed round last year, we have been in full swing growing the team, developing products and building capacity with our proprietary production system. We are now in a strong position as we push into this next phase of the company's growth,” Spanton added. ABOUT PROVECTUS ALGAE Provectus Algae is an Australian biotech company that programs algae to produce the world's most valuable specialty ingredients. By accelerating nature, their team is able to optimise unique microalgae to produce a whole new range of natural products, in a process described as “precision photosynthesis”. Using next-generation techniques the company has also developed a synthetic biology stack that complements and competes with existing production platforms to deliver high-performance and sustainable products.

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MEDICAL

Pfizer and BioNTech Begin Rolling Submission of Biologics License Application for FDA Approval of COVID-19 Vaccine in the U.S

Pfizer, BioNTech | May 10, 2021

Pfizer Inc. and BioNTech SE confirmed today the filing of a Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in people aged 16 and above. Companies will send data to help the BLA to the FDA on a rolling basis in the coming weeks, along with a proposal for Priority Review. If the BLA has been completed and duly approved for review by the FDA, the FDA will set a target date for a determination under the Prescription Drug User Fee Act (PDUFA). The Pfizer-BioNTech COVID-19 Vaccine is now available in the United States under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) on December 11, 2020. Since then, the firms have distributed more than 170 million doses of the vaccine in the United States. The next step in the comprehensive FDA evaluation process is the submission of a BLA, which includes longer-term follow-up data for acceptance and approval. Pfizer and BioNTech started the BLA process by providing the nonclinical and clinical data needed to justify the licensure of the COVID-19 vaccine for use in people aged 16 and up. This covers the most recent analyses from the pivotal Phase 3 clinical trial, in which the vaccine's effectiveness and safety profile were detected up to six months after the second dose. In the coming weeks, the companies will submit the required manufacturing and facility details for licensure, completing the BLA. Pfizer and BioNTech have since submitted to expand the new EUA for their COVID-19 vaccine to cover individuals aged 12 to 15. The firms plan to send a supplemental BLA to facilitate vaccine licensure in this age group until the requisite data is available six months after the second vaccine dose. BioNTech and Pfizer collaborated to create the Pfizer-BioNTech COVID-19 Vaccine, which is built on BioNTech's patented mRNA technology. BioNTech is the European Union's Marketing License Holder, as well as the holder of emergency use authorizations or similar in the United States (along with Pfizer), the United Kingdom, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries. The Pfizer-BioNTech COVID-19 Vaccine has not been authorized or licensed by the United States Food and Drug Administration (FDA), but it has been authorized for emergency use by the FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in people aged 16 and up. The emergency use of this product is only permitted for the duration of the declaration the circumstances justify the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act until the declaration is terminated or the authorization is revoked sooner. About Pfizer At Pfizer, they utilize science and its global resources to deliver treatments to patients that significantly extend and change their lives. In the discovery, development, and manufacture of health care products, including innovative medicines and vaccines, they aim to set the benchmark for consistency, safety, and value. Every day, Pfizer colleagues collaborate in developing and emerging markets to advance wellness, prevention, treatments, and remedies for today's most feared diseases. As one of the world's leading innovative biopharmaceutical firms, they partner with health care providers, governments, and local communities to promote and improve access to reliable and affordable health care around the world. About BioNTech Biopharmaceutical New Technologies is a next-generation immunotherapy firm that is developing novel cancer and other severe disease therapies. For the accelerated production of new biopharmaceuticals, the company makes use of a diverse set of computational discovery and therapeutic drug platforms. Its oncology product candidates include individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies, and small molecules from Fosun Pharma and Pfizer.

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