Arbor Vita Launches Open Platform COVID-19 Antibody Test Expanding Access To Higher Quality Diagnostics

Arbor Vita | June 08, 2020

Arbor Vita announced today the availability of its CoVisa™ IgG ELISA-based test for antibodies associated with the novel coronavirus (COVID-19). The test has been found to have a 100 percent sensitivity (positive percentage agreement), and 99.24 percent specificity (negative percentage). Additional validation testing is ongoing in independent laboratories. The company has notified the U.S. Food and Drug Administration under the Emergency Use Authorization (EUA) process. Arbor Vita's CoVisa™ test presents an opportunity to greatly enhance antibody test availability in the U.S.  Currently there are approximately 26,000 high complexity CLIA labs in the U.S. capable of processing COVID-19 antibody tests on ELISA systems. Approximately 200 to 2,000 of those labs have systems that can run currently available tests on a closed platform, that is on a particular manufacturer's laboratory equipment. CoVisa can be used by the additional 24,000 labs that do not have such equipment. This is especially important since those high complexity CLIA labs will not be able to offer COVID-19 antibody testing after the removal by the FDA of 28 non-functioning antibody tests that do not use the higher accuracy ELISA method. Arbor Vita has commenced production of all elements of its test including reagents within its U.S facilities and will initially deliver 2,000,000 tests by the end of June and expand production to 1,000,000 per day by the end of July.

Spotlight

The University of Alabama at Birmingham's Master of Science in Biotechnology Program is designed to train you for a career in a sector that is adding new jobs at nearly twice the rate of the overall national private sector. You will learn the practices and principles of both science and business that are necessary for you to succeed in technology and product development. The biotechnology curriculum allows you to adapt your coursework based on your interests including drug development, regulatory affairs, technology transfer and marketing.

Spotlight

The University of Alabama at Birmingham's Master of Science in Biotechnology Program is designed to train you for a career in a sector that is adding new jobs at nearly twice the rate of the overall national private sector. You will learn the practices and principles of both science and business that are necessary for you to succeed in technology and product development. The biotechnology curriculum allows you to adapt your coursework based on your interests including drug development, regulatory affairs, technology transfer and marketing.

Related News

INDUSTRIAL IMPACT

Sirona Biochem Signs International Partnership Agreement with Wanbang Biopharmaceuticals

Sirona Biochem Corp. | November 24, 2022

Sirona Biochem Corp. announces that, subsequent to the LOI, Sirona and Wanbang Biopharmaceuticals have signed an expanded, international partnership agreement to collaborate on licencing Sirona’s SGLT2 inhibitor, TFC-039, as a pharmaceutical treatment in both animal and human health. The agreement adds human health to the partnership as a result of new licencing opportunities currently in due diligence. Wanbang and Sirona initially signed a licensing agreement for TFC-039, whereby Wanbang obtained the rights to develop the compound as a diabetes treatment in China and Sirona retained the global rights. Sirona has since been in discussions with animal health companies to advance TFC-039 as a treatment for diabetes and chronic kidney disease in companion animals. SGLT2 inhibitors provide an opportunity to treat inflicted animals with an oral medication as opposed to the traditional method of daily insulin injections. More recently, Sirona has entered into due diligence with a large pharmaceutical company with a regional interest in developing the compound for human diabetes. Together, Sirona and Wanbang share extensive knowledge and scientific results of TFC-039. Partnering will significantly increase the speed to third-party partnerships and commercialization. The shared data spans over 12 years of research and development, and includes in vitro and in vivo preclinical work, multiple clinical studies, advanced manufacturing process development and the ability to commercially manufacture TFC-039. “We have a long-standing relationship with Wanbang and are excited to combine our two companies’ expertise to license TFC-039. Wanbang has invested millions of dollars into the clinical stage research and development of the manufacturing processes for TFC-039. These pieces of data are critical to large organizations and will greatly increase the opportunities to move forward. The probability of a successful licensing agreement has been made much stronger by leveraging our alliance with Wanbang. We have had a successful year building Sirona’s pipeline, with positive movement on all projects and we’re looking forward to continuing this success with our SGLT2 inhibitor as well as our antiviral and anti-aging projects in 2023.” Dr. Howard Verrico, CEO About Wanbang Biopharmaceuticals and Fosun Pharmaceuticals Wanbang Biopharmaceuticals develops, manufactures, and markets drugs with indications for chronic disease treatment, antibiotics, and other endocrine diseases in China. Founded in 1981, the company is headquartered in Xuzhou, China, and is a subsidiary of Shanghai Fosun Pharmaceutical Group. Fosun is a leader in the pharmaceutical industry and is regarded as one of the top five domestic pharmaceutical companies in China. About Sirona Biochem Corp. Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential. Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants.

Read More

MEDTECH

ElevateBio BaseCamp Unveils its LentiPeakTM Lentiviral Vector Platform

ElevateBio, LLC | November 07, 2022

ElevateBio, LLC (ElevateBio), a technology-driven company focused on powering transformative cell and gene therapies, announced the unveiling of ElevateBio BaseCamp’s proprietary LentiPeakTM lentiviral vector platform. LentiPeak is a serum-free, suspension-based, scalable production platform that has demonstrated high volumetric productivity of therapeutically relevant vector yields that meet regulatory guidelines. LentiPeak will enable efficient transition for cell and gene therapies from preclinical stage through clinical development and commercialization with accelerated timelines and reduced manufacturing costs.The LentiPeak platform leverages ElevateBio BaseCamp’s end-to-end process and analytical development expertise and scientific leadership and builds upon the company’s current Good Manufacturing Practice (cGMP) manufacturing capabilities for research, clinical and commercial cell and gene therapies, and regenerative medicines. “As a 30-year veteran of the cell and gene therapy industry, I’ve witnessed the immense advancement of lentiviral vector technology from its infancy to the current landscape with six FDA-approved lentiviral vector-derived cell and gene therapies, The LentiPeak platform is made possible by ElevateBio’s strong scientific foundation, industry-leading expertise, and the investments we’ve made into viral vector production. Our pioneering work continues to be the basis for our continued innovation to drive many more therapies through development to commercialization for our partners.” -Mitchell Finer, Ph.D., Co-founder and President of R&D, ElevateBio ElevateBio BaseCamp’s LentiPeak platform offers a robust and scalable platform process for development and cGMP manufacturing of lentiviral vectors. The LentiPeak platform utilizes a serum-free suspension process capable of producing clinically relevant lentiviral vectors with high titers ranging from 1x10^8 TU/ml to 1x10^9 TU/ml, suitable to meet various therapeutic program needs from preclinical scale to commercial scale supply. The LentiPeak platform can also be seamlessly integrated into cell therapy programs with ElevateBio’s ability to conduct both vector and cell production activities. By leveraging the aligned process unit operations, materials, analytics, and manufacturing expertise at ElevateBio BaseCamp, the LentiPeak platform will simplify the product development and commercialization lifecycle, reducing complexity and ensuring comparability between early-stage and pivotal trials. “Our team of industry-leading experts have developed next-generation platform-based processes that are designed to address lentivirus manufacturing challenges head-on. With our partners’ needs in mind, our proprietary LentiPeak platform has demonstrated leading vector titers with high potency, and process scalability to help our partners de-risk vector production, right from the start, At ElevateBio BaseCamp, we are ever committed to simplifying the complex cell and gene therapy landscape to enable our partners to rapidly progress their therapeutic programs and make these therapies more accessible to patients in need.” -Andrew Sandford, President, ElevateBio BaseCamp About ElevateBio: ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built state-of-the-art facilities, and integrated diverse technology platforms, including gene editing, induced pluripotent stem cells (iPSCs), and protein, vector, and cellular engineering, necessary to drive innovation and commercialization of cellular and genetic medicines. In addition, ElevateBio BaseCamp in Waltham, MA, is a purpose-built facility offering process innovation, process sciences, and current Good Manufacturing Practice (cGMP) manufacturing capabilities. It was designed to support diverse cell and gene therapy products, including autologous, allogeneic, and regenerative medicine cell products and viral vector manufacturing capabilities. Through BaseCamp and its enabling technologies, ElevateBio is focused on growing its collaborations with industry partners while also developing its own portfolio of cellular and genetic medicines. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.

Read More

INDUSTRIAL IMPACT

Applied DNA Announces Receipt of Largest Single Purchase Order for LinearDNA™ To-Date

Applied DNA Sciences | October 11, 2022

Applied DNA Sciences, Inc. a leader in PCR-based DNA technologies, announced that it received its largest single purchase order for LinearDNA™ valued above the mid-six-figures. The order was placed under a long-standing supply agreement for the bulk manufacture of LinearDNA for a global manufacturer of in vitro diagnostics. Under the terms of the repeat order, the Company will deliver quantities of LinearDNA to the customer in the current quarter, with the full order expected to be fulfilled over the subsequent three quarters. LinearDNA is produced using an enzymatic manufacturing platform that eliminates the use of fermenters and bacteria required by plasmid DNA, the industry’s current manufacturing standard for DNA. LinearDNA eliminates many of the challenges associated with current plasmid-based DNA manufacturing and produces a DNA product without the risks of bacterial contamination and non-target DNA sequences. The enzymatic process provides the means to optimize a customer-specific chemistry and sequence of LinearDNA. This capability has been leveraged for diagnostic applications, including today's announced repeat order, and is commonly used when customers order LinearDNA for use as IVT templates for RNA production. “The application of DNA-based probes in molecular diagnostics is rapidly expanding to give the industry powerful new tools to enhance the diagnosis of infectious diseases, genetic disorders, and malignancies. Our proprietary enzymatic approach to manufacturing DNA via PCR underpins our ability to produce DNA more efficiently and rapidly relative to other DNA production methods and at scale. Applying this capacity also to the manufacture of therapeutic DNA for the next generation of genetic medicines, we believe LinearDNA sits at the intersection of two growing life sciences segments that hold the potential to transform human health.” Dr. James A. Hayward, president and CEO of Applied DNA About Applied DNA Sciences Applied DNA Sciences is a biotechnology company developing technologies to produce and detect deoxyribonucleic acid . Using PCR to enable both the production and detection of DNA, we operate in three primary business markets: (i) the manufacture of DNA for use in nucleic acid-based therapeutics; (ii) the detection of DNA in molecular diagnostics testing services; and (iii) the manufacture and detection of DNA for industrial supply chain security services. The Company’s common stock is listed on NASDAQ under the ticker symbol ‘APDN,’ and its publicly traded warrants are listed on OTC under the ticker symbol ‘APPDW.’

Read More