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Archive for category: Corona News

Corona News

Oxford companies join forces to scale up production of Covid-19 reagents

, 26 August 2020/in Corona News, E-News /by 3wmedia

OXGENE and The Native Antigen Company have joined forces to scale up production of SARS-CoV-2 (COVID-19) reagents by combining OXGENE’s proprietary Adenoviral Protein Machine Technology with The Native Antigen Company’s antigen development expertise. Together, OXGENE and The Native Antigen Company will aim to scale their antigen manufacturing capabilities to deliver high-purity, recombinant proteins for the development of diagnostics and vaccines.
Together they are developing an improved, scalable approach to SARS-CoV-2 antigen manufacture. The Native Antigen Company was one of the first recognised suppliers of SARS-CoV-2 antigens in February 2020, demonstrating their ability to rapidly support the diagnostic and vaccine industries with high-quality infectious disease reagents. OXGENE’s Protein Machine Technology allows for the scalable production of viral proteins in mammalian cells using their proprietary adenoviral expression vector. Through genetic modification, the adenovirus is ‘tricked’ into making SARS-CoV-2 proteins rather than its own, thereby harnessing the innate power of highly scalable viral protein production.
The Native Antigen Company’s recombinant SARS-CoV-2 antigens are produced in mammalian cells to ensure full glycosylation and proper protein folding, both of which are essential for full biological and antigenic activity. The rapid scale up production of SARS-CoV-2 antigens is critical for the development of widely available diagnostic tests.
Unlike the PCR tests that are currently being used, these diagnostics will be able to confirm past infections and determine levels of immunity to SARS-CoV-2. This could be invaluable for disease modelling and public health policy, as true transmission rates and case fatality rates can be determined. These tests could also be instrumental for the diagnosis of healthcare workers who have been exposed to the virus to ensure that they have developed natural immunity before returning to work, and to help measure patient immune responses for the rapid development of a SARS-CoV-2 vaccine.
Dr Ryan Cawood, Chief Executive, OXGENE, said: “Our novel Protein Machine Technology represents a significant development in the rapid and scalable generation of high-quality viral proteins. We’re delighted that by collaborating with The Native Antigen Company, we can take advantage of our technology to support the needs of researchers racing to develop much-needed diagnostics and vaccines against COVID-19.”
This collaboration builds on a long-standing collegiate relationship between the two Oxford-based businesses as they work towards developing more scalable technologies for the diagnosis of disease, and the cost-effective manufacture of high-quality diagnostics and vaccines.
OXGENE and The Native Antigen Company aim to complete the first validation of this new paradigm in protein expression within the next month, which could have a demonstrable impact on the race to develop diagnostic kits and vaccines against this virus.
For further information about The Native Antigen Company’s Coronavirus Antigens, please visit: https://thenativeantigencompany.com/coronavirus-dashboard/

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Johnson & Johnson aims to produce a billion doses of COVID-19 vaccine

, 26 August 2020/in Corona News, E-News /by 3wmedia

Johnson & Johnson has announced the selection of a lead COVID-19 vaccine candidate on which it expects to initiate human clinical studies by September at the latest with the first batches of the vaccine available for emergency use authorization in early 2021.
In addition, the company announced the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA).
Johnson & Johnson also said the company will rapidly scale up its manufacturing capacity with the goal of providing a global supply of more than one billion doses of the vaccine.
Through the new partnership, BARDA and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. The company says will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services.
Commenting on the initiative, Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said: “The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible. As the world’s largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day. Johnson & Johnson is well positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic.”
The company’s expansion of its manufacturing capacity will include the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said: “We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021.” In addition to the vaccine development efforts, BARDA and Johnson & Johnson have also expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The company’s aim is to identify potential treatments against the novel coronavirus. Johnson & Johnson and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.

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DefiniGEN launches tool to support in vitro intestinal research of Covid-19

, 26 August 2020/in Corona News, E-News /by 3wmedia

UK-based iPSC (induced pluripotent stem cells) disease modelling company DefiniGEN has identified iPSC-derived intestinal organoids that could be used to help structure in vitro studies of the biology of SARS-CoV-2 infection across cohorts of multiple patients.
While SARS-CoV-2 primarily targets the respiratory system, studies have shown that it also infects and multiplies within the intestinal epithelium. IPSC-derived organoids exhibit characteristics that closely mimic the in vivo intestinal epithelium, making them a valuable surrogate model for studying the virus.
The company says their iPSC-derived intestinal organoids provide a unique in vitro system to model the human intestine. The organoids display a polarized epithelium and harbour a mixture of cell types normally present in the primary intestinal epithelium barrier in vivo, including goblet cells, Paneth cells, enterocytes, LRG5+ stem cells, and enteroendocrine cells. The organoids polarise, form crypt structures and grow villi at the apical surface, and are shown to secrete mucus in a similar manner to primary human gut tissue.
DefiniGEN points out that several studies have proven that angio-tensin-converting enzyme 2 (ACE2) expression in host cells is required for SARS-CoV-2 recognition and infection. Activity of membrane proteases such as TMPRSS2 cleaves the coronavirus’ Spike protein and facilitates the membrane fusion with the host cell. Human intestine is one of the few human tissues with high expression of both ACE2 and TMPRSS2 therefore is a good candidate to study Covid-19 and the mechanisms of the SARS-CoV-2 infection.
Additionally, DefiniGEN have a platform to generate various patient-derived intestinal models which could support population studies, using many different donors with diverse ethnic profiles.
Such studies are useful as there is growing evidence that ethnic differences are a major factor in patients showing a severe response to Covid-19.
DefiniGEN’s differentiation platform is optimized to enable successful generation of intestinal organoids from a diverse range of patients. Patient skin fibroblasts or PBMCs can first be reprogrammed to iPSC, and then differentiated to produce mature intestinal organoids which carry the original patient genetics, and so manifest a gut model specific to that donor.
For more information, visit www.definigen.com/products/intestinal/covid-19

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Roche to launched COVID-19 antibody test in early May

, 26 August 2020/in Corona News, E-News /by 3wmedia

Roche will develop its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to SARS-CoV-2 and launch it in early May in countries accepting the CE mark. The company says it is actively working with the FDA for an Emergency Use Authorisation.
The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, using human serum and plasma drawn from a blood sample, to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The test may be used in epidemiological research to help better understand the spread of the disease and may also be used together with molecular tests to aid in the diagnosis of suspected COVID-19 patients. Hospitals and reference laboratories can run the test on Roche’s cobas e analysers, which are widely available in laboratories around the world.
Roche notes that antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms. Additionally, the test can support priority screening of high risk groups, such as healthcare workers, food supply workers who might already have developed a certain level of immunity and can continue serving and/or return to work.
Severin Schwan, CEO Roche Group, said: “Following the launch of our high-volume PCR test in mid-March to detect active infection of the disease, we are now going to launch a new antibody test in early May. Every reliable test on the market serves its purpose for healthcare systems to help us overcome this pandemic. Roche is collaborating closely with health authorities and ramping up production to ensure fast availability of the test globally.”
Thomas Schinecker, CEO Roche Diagnostics, commented: “The antibody test is an important next step in the fight against COVID-19. Roche’s antibody test can be quickly scaled and made broadly available around the world as our instrument infrastructure is already in place.”

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Avacta Group collaborates with Adeptrix to develop a high throughput Covid -19 antigen test

, 26 August 2020/in Corona News, E-News /by 3wmedia

UK-based Avacta Group, the developer of Affimer biotherapeutics and reagents, will collaborate with US-based Adeptrix to develop a high throughput Covid -19 antigen test using Adeptrix’s proprietary bead-assisted mass spectrometry (BAMS) platform.
The Affimer-based BAMS coronavirus antigen test that will provide clinicians with a significant expansion of the available testing capacity for Covid-19 infection in hospitals.
Adeptrix’s novel BAMS platform combines enrichment of the sample to improve sensitivity with the power of mass-spectrometry to improve specificity. Hundreds of samples per day can be analysed by a single technician using BAMS, exceeding the capacity of single PCR machine, making BAMS a very attractive high throughput technique for Covid-19 screening in the clinical setting.
The diagnostic test will allow hospitals around the world to utilise their existing installed base of mass spectrometers that are not currently used for Covid-19 testing, thus contributing significantly to the increase in global testing capacity. Avacta’s recently developed Affimer reagents that bind the SARS-COV-2 spike protein will be used to provide the capture and enrichment of the virus particle from the sample which could be saliva, nasopharyngeal swabs or serum.
The companies are aiming to have a BAMS test ready for clinical validation, regulatory approval and manufacturing in June. Adeptrix and Avacta are already in discussion with large-scale manufacturing partners to rapidly deploy this new high throughput test.
Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: “We believe that the BAMS test will be hugely attractive as an adjunct to PCR testing because it uses laboratory equipment that is already in hospital labs but not currently used for Covid-19 testing so it provides incremental testing capacity.
I have made it clear that we intend to partner the SARS-COV-2 spike protein Affimer reagents with several select companies to support antigen test development on multiple diagnostic test platforms. This will contribute most effectively to the urgent need to increase antigen testing capacity globally and maximise the commercial return to Avacta. Adeptrix is one example of this and other discussions are underway. I look forward very much to further updating the market in the near future.”
Dr. Jeffrey C. Silva, Director of Product Development, Adeptrix Corporation commented: “Mass spectrometry can enhance the diagnostic utility of immunoassays, as it is capable of monitoring both existing and emerging viral strains by accurately measuring the molecular components of the virus. BAMS provides an ideal multiplexing platform to obtain higher specificity for monitoring Covid-19 infection.”

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Pharming Ruconest

, 26 August 2020/in Corona News, E-News /by 3wmedia

The Netherlands-based Pharming Group, a specialty pharmaceutical company, have seen encouraging results from it RUCONEST (recombinant human C1 inhibitor) treatment in patients with confirmed COVID-19 infections. The patients were treated under a compassionate use program at the University Hospital Basel, Switzerland.
Dr. Michael Osthoff, University Hospital Basel, Switzerland and the treating physician, said: “Although this is an uncontrolled, small treatment experience, the results demonstrate the potential effectiveness of using RUCONEST as an anti-inflammatory approach to inhibit the complement and contact systems after SARS-CoV-2 infection.”
Four male patients and one female patient (between 53-85 years of age) with COVID-19 and suffering from related severe pneumonia, who did not improve despite standard treatment, including hydroxychloroquine and lopinavir/ritonavir, were administered RUCONEST at an initial dose of 8400 U, followed by 4200 U every 12 hours for three additional doses. No allergic reactions or drug related adverse events were reported.
Following treatment with RUCONEST, fever resolved in four of the five patients within 48 hours, and laboratory markers of inflammation decreased significantly (CRP, IL-6). Soon thereafter, the patients were discharged from the hospital as fully recovered. One patient had increased oxygen requirement and was temporarily transferred to the ICU for intubation, but over the subsequent days recovered and was released from the ICU.
Following these initial results, a multinational, randomized, controlled, investigator-initiated clinical trial with up to 150 patients with confirmed COVID-19 infections, requiring hospitalisation due to significant COVID-19 related symptoms is planned. The study will be led by Dr. Osthoff.
RUCONEST® is commercialised by Pharming in the US and in Europe, and the company holds all other commercialisation rights in other countries not specified below. In some of these other countries distribution is made in association with the HAEi Global Access Program (GAP). RUCONEST is distributed in Argentina, Colombia, Costa Rica, the Dominican Republic, Panama, and Venezuela by Cytobioteck, in South Korea by HyupJin Corporation and in Israel by Kamada.
Pharming’s technology platform includes a unique production process that has proven capable of producing industrial quantities of pure high quality recombinant human proteins in a more economical and less immunogenic way compared with current cell-line based methods.

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BIOHIT supplies COVID-19 detection kits in the UK

, 26 August 2020/in Corona News, E-News /by 3wmedia

BIOHIT Healthcare is distributing test kits for the diagnosis of both current and past COVID-19 infections to help in the fight against coronavirus in the UK. The new product line includes the MutaPLEX® Coronavirus kit from Immundiagnostik AG (IDK) – a real-time RT-PCR assay to screen for infected individuals – and Epitope Diagnostics Inc’s (EDI’s) immunodiagnostic tests for IgM and IgG COVID-19 antibodies, to detect past infections.
The IDK MutaPLEX coronavirus screening assay allows the detection of SARS-CoV-2 viral RNA in a variety of biological specimens, especially nasal/throat swabs. This real time RT-PCR kit contains all the reagents, primers and dual-labelled probes required for the amplification and simultaneous differentiation of RNA from SARS-CoV-2 and other betacoronaviruses, as well as house-keeping genes designed to prevent false negative results due to insufficient sample collection or transport problems.
EDI’s Novel Coronavirus COVID-19 ELISA kits provide qualitative detection of antibodies in patient serum, indicating a past COVID-19 infection. The IgM assay provides the earliest immunodiagnostic indication of an infection, while the IgG test can be used to aid detection and provide an indication of long-term immunological response, making it particularly useful in cases where clustering is suspected or differential diagnosis is required.
These tests extend and complement BIOHIT’s repertoire of diagnostic kits for gastroenterology, aiding the evaluation of patients with both GI and upper respiratory complaints, as COVID-19 may include stomach and bowel symptoms in some cases. Inflammatory bowel disease patients being treated with immunosuppressive agents should also be considered at high risk for COVID-19, making differential diagnosis essential.

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Nova Biomedical to Host Webinar on COVID-19 Bedside Glucose Management

, 26 August 2020/in Corona News, E-News /by 3wmedia

Waltham, MA–Nova Biomedical to host “COVID-19 Bedside Glucose Management: Risk of Ascorbic Acid and Hematocrit Interference,” a webinar led by Charbel Abou-Diwan, PhD, Director of Medical and Scientific Affairs, to help inform and support healthcare workers treating COVID-19 patients.
Interest in the antioxidant properties of ascorbic acid use in critically ill patients is growing especially during the in the COVID-19 pandemic. As clinicians search for effective treatments for COVID-19, sepsis, and other critical illness, high dose ascorbic acid is widely considered. These patients are admitted to the ICU where routine POC glucose monitoring becomes part of their care path. Unfortunately, two widely used hospital glucose meters have a substantial interference from ascorbic acid that radically elevates glucose meter results, leading to potential adverse events. This webinar examines the risk of inaccurate glucose meter results due to ascorbic acid interference and how hospitals can protect their patients and protect themselves against this threat.
The webinar will be delivered on three dates: Thursday, April 30th at 2:00 PM EST, Thursday, May 28th at 1:00 PM EST, and Thursday, June 18th at 4:00 PM EST. Attendees can earn educational credits for attending and can register online at novabiomedical.com/poc/glu/covid About Nova Biomedical
Incorporated in 1976 and based in Waltham, MA, Nova Biomedical is a world leader in the development and manufacturing of state-of-the-art, whole blood, point-of-care and critical care analyzers, as well as providing the biotechnology industry with the most advanced instruments for cell culture monitoring. Nova is one of the fastest growing in vitro diagnostic companies in the world. Nova’s biosensor technology is incorporated in products ranging from handheld meters for glucose self- and point-of-care testing to critical care whole blood analyzers designed for rapid measurement of over 20 analytes. Nova’s biotechnology-specific BioProfile line has pioneered comprehensive cell culture testing, providing over 20 critical cell culture tests with over 12 unique instrument offerings for broad range of cell culture applications. Nova employs over 1,300 people worldwide and has wholly owned subsidiaries located in Brazil, Canada, Great Britain, France, Spain, Italy, Germany, Switzerland, and Japan. www.novabiomedical.com

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IVD assay iAMP Covid-19 Detection Kit receives CE Mark

, 26 August 2020/in Corona News, E-News /by 3wmedia

Fujirebio Europe has received the CE mark for the molecular IVD assay iAMP Covid-19 Detection Kit from its partner Atila Biosystems. The qualitative detection kit is based on real-time fluorescent reverse transcription isothermal amplification, eliminating the need for RNA extraction.
The detection kit was also granted Emergency Use Authorization by the US Food and Drug Administration on April 10.
The iAMP COVID-19 Detection Kit can be run on a Real-Time PCR PowerGene 9600 Plus or any other qPCR automate capable of measuring fluorescence in FAM/HEX channel in real-time.
The new iAMP COVID-19 molecular assay complements the existing panel of biomarkers available on the LUMIPULSE® G System for infection (PCT, Ferritin), inflammation (IL-6) and epithelial lung injury (KL-6) to predict disease severity in patients infected with SARS-CoV-2.
Products from Atila Biosystems are available through Fujirebio’s European affiliates and through a large portion of Fujirebio’s existing or new European distribution network.
For more information, visit: www.fujirebio.com/en/contact

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Cobra Biologics and the Karolinska Institutet collaborate to develop COVID-19 vaccine

, 26 August 2020/in Corona News, E-News /by 3wmedia

Cobra Biologics (Cobra), an international contract development and manufacturing organization (CDMO) for biologics and pharmaceuticals, and the Karolinska Institutet (KI), one of the world’s leading medical universities, announced 30 March they have been awarded €3 million emergency funding by Horizon 2020 for research and development, and phase I clinical trial testing of a DNA vaccine against COVID-19, as part of the OPENCORONA consortium to support global efforts tackling the pandemic. Partners in the consortium also include Karolinska University Hospital, Public Health Authority (FoHM), IGEA, Adlego AB and Giessen University.
The project is called OPENCORONA and the application, ‘Rapid therapy development through Open Coronavirus Vaccine Platform’, was one of the first two to be successfully selected by the European Commission, with 17 applications chosen out of 91, receiving €47.5 million in total. The aim of the project is to manufacture a DNA vaccine, which will be delivered to patient muscle to generate a viral antigen on which the immune system then reacts. The ‘open’ project will utilise Cobra’s 50L DNA suite in Sweden to produce the plasmid DNA. The plasmid production will support the vaccine development process in accordance with GMP and with a new kind of ‘open’-ness that will help to speed the fight against COVID-19 by making relevant data and research results available to the wider scientific community.
KI notes that “genetic analysis shows that the SARS-CoV-2 envelope and receptor binding domain only has a 75% homology with other human coronaviruses. Thus, existing immunotherapies and vaccine candidates against other coronaviruses, such as SARS, will not be useful against SARS-CoV-2. We will use the DNA vaccine platform as this is currently the most rapid and robust vaccine platform. We have generated several chimeric SARS-CoV-2 genes and will select for the most potent DNA vaccine/immunotherapy candidate delivered by in vivo electroporation that protects against SARS-CoV-2 infection and/or disease in animal models and take this to phase I clinical testing.”
To date, no approved human COVID-19 immunotherapy or vaccine exists, and in response to the outbreak, speed in therapy and vaccine R&D is critical. Harnessing each partner’s expertise and experience in reliable development manufacturing, the OPENCORONA consortium is using the DNA vaccine platform as it is currently one of the most rapid and robust vaccine platforms available. First trials in humans will begin in 2021, and will take place at the Karolinska University Hospital.
Commenting on the funding, Matti Sällberg, Head of Department of Laboratory Medicine, Karolinska Institutet, commented: “The need to find an effective vaccine is urgent and we are working as quickly as possible to find one. With this funding from the EU we will have secured a significant part of the financing going forward, which means that we can focus entirely on the research. It is a relief to know that we are now financed all the way to studies in humans.”

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