Point-of-care (POC) testing has the potential to provide results in a much shorter time than centralized lab testing, allowing faster implementation of appropriate treatment. This article discusses the technological developments in POC tests, considerations for the implementation of a POC system, as well as how to ensure accurate and reliable results.
https://clinlabint.com/wp-content/uploads/sites/2/2020/08/NEWS_CLI_CLINICAL_MICROBIOLOGY.jpg70910003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:31:372021-01-08 11:07:56Highlights and hurdles of molecular point-of-care systems for infectious disease diagnosis
In response to the global COVID-19 pandemic, Beckman Coulter, a global leader in clinical diagnostics, announced 31 March that it is developing assays to identify IgM and IgG antibodies to SARS-CoV-2. Research has shown that after infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies that can be detected with IgM and IgG tests.
The assays will be designed for use on any of Beckman Coulter’s high-throughput Access family of immunoassay systems, including the Access 2 and DxI series, which can be found worldwide.
“Antibody assays play a critical role in understanding the level of immunity an individual has developed against SARS-CoV-2,” said Kathleen Orland, Senior Vice President and General Manager for Beckman Coulter’s Chemistry and Immunoassay Business. “This type of understanding could help identify those who would require a vaccine, once available, or when an infected individual could safely return to work.”
Shamiram R. Feinglass, MD, MPH, Chief Medical Officer, Beckman Coulter, added: “With the ability to assess a patient’s immunity to SARS-CoV-2, this testing modality may enable clinicians to clear hospital staff, emergency responders, and others to get back to work with an indication that they have had prior exposure and therefore have built an immunity to the disease. This test could allow those without immunity to be identified and kept safe until the pandemic subsides.”
Beckman Coulter operates within the Danaher Corporation, together with a collection of the world’s leading diagnostic companies, all on the front line in the fight against coronavirus.
Once the assays are finalized, Beckman Coulter intends to achieve CE mark certification and to follow FDA’s Emergency Use Notification process.
For the latest information on the new assays, visit www.beckmancoulter.com/coronavirus
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Sartorius, a leading international partner of life science research and the biopharmaceutical industry, has supported CanSino Biologics Inc. (“CanSinoBIO”) and Maj. Gen. Chen Wei’s team at the Institute of Bioengineering at the Academy of Military Medical Sciences (“Institute of Bioengineering”) in China in their development of the first vaccine candidate against the novel coronavirus SARS-CoV-2 to enter clinical trials. CanSinoBIO and the Institute of Bioengineering used Sartorius’ BIOSTAT® STR single-use bioreactor system for the upstream preparation of the recombinant vaccine, thus ensuring the rapid linear amplification of the adenovirus vector (Ad5-nCoV) and ultimately saving time during development.
The BIOSTAT® STR single-use bioreactor system comes with updated BioPAT® toolbox for process monitoring, as well as Flexsafe® STR integrated, single-use bioprocess bags. It has been proven to be used for vaccine manufacturing because it offers rapid scalability and flexibility to adapt to fluctuating demand. The single use bags prevent cross-contamination, and reduce the time needed for washing and sanitation typical in stainless steel bioreactors. As such, the amount of time needed to prepare a vector for a vaccine is shortened from several months to (several) weeks.
“We are pleased that we can help our clients and partners accelerate vaccine development while maintaining compliance with safety protocols, thereby allowing us to contribute to better health for more people,” said Huang Xian, Head of Marketing at Sartorius BPS China.
This is the second collaboration from Sartorius, CanSinoBIO, and the Institute of Bioengineering to accelerate vaccine development. In October 2017, Sartorius’ BIOSTAT® STR50 bioreactor system was used during CanSinoBIO’s and the Institute of Bioengineering’s joint development of a recombinant vaccine against Ebola virus disease. This was the first registered Ebola vaccine in the world.
https://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png003wmediahttps://clinlabint.com/wp-content/uploads/sites/2/2020/06/clinlab-logo.png3wmedia2020-08-26 09:31:372021-01-08 11:07:55Sartorius supports development of vaccine candidate against SARS-COV-2 to enter clinical trials
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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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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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.
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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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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Cambridge, UK-based Horizon Discovery Group, specializing in the application of gene editing and gene modulation for cell line engineering, has released an arrayed CRISPR knockout screening service for primary human B cells to its cell-based screening services.
The new B cell screening service, the first of its kind in the market, will enable researchers to identify genes that affect the function of B cells and examine how this impacts other immune cell types, particularly in infectious diseases, cancer, and auto-immune disorders, such as COVID-19, Burkitt’s lymphoma and multiple sclerosis respectively.
Primary human cells – cells that are freshly isolated from donors – are known to be difficult to study in the lab. However, working with these cells brings scientists one step closer to healthy or diseased micro-environments, enabling them to better understand disease etiology and therapeutic mechanisms, and thereby advance drug discovery and development programs.
“The interest in harnessing the immune system for effective therapies continues to grow, with the global cell therapy market predicted to reach $8.21bn by 2025. Expanding our services to encompass screening of both primary T and B cells is another example of our commitment to apply decades of gene editing experience in support of drug discovery and development for the treatment of human disease,” said Terry Pizzie, CEO, Horizon Discovery.
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As the COVID-19 pandemic progresses in countries around the globe, there is an urgent need for rapid and reliable point-of-need detection testing. Dolomite Microfluidics and Mologic are working together to accelerate the development and launch of these tests.
UK-based Mologic is a leading developer of rapid response diagnostic tests for diseases such as malaria and Ebola virus disease. Clients include the Bill & Melinda Gates Foundation, where Mologic is leveraging its core technology through its Centre for Advanced Rapid Diagnostics (CARD) to develop the next generation of ultra-sensitive point-of-care diagnostics which are easy to use andinexpensive to manufacture – critical to the success of many global health programmes. Most recently, Mologic has received UK Government funding to develop and manufacture a high sensitivity test for COVID-19 that generates results within minutes – rather than hours or days – without the need for a laboratory or specialist equipment.
The technology behind these tests involves the use of precisely manufactured nanoparticles. Dolomite specialises in equipment that allows the development and scale-up of precision nanoparticles. This is achieved by using microfluidic technology to retain advanced control of production conditions. Dolomite is working with Mologic to combine ground-breaking diagnostic technology with continuous flow microfluidic manufacturing processes to accelerate the validation and release of Mologic’s COVID-19 diagnostic test.
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Highlights and hurdles of molecular point-of-care systems for infectious disease diagnosis
, /in E-News, Editors' Picks /by 3wmediaPoint-of-care (POC) testing has the potential to provide results in a much shorter time than centralized lab testing, allowing faster implementation of appropriate treatment. This article discusses the technological developments in POC tests, considerations for the implementation of a POC system, as well as how to ensure accurate and reliable results.
Beckman Coulter to produce antibody assays for Covid-19
, /in Corona News, E-News /by 3wmediaIn response to the global COVID-19 pandemic, Beckman Coulter, a global leader in clinical diagnostics, announced 31 March that it is developing assays to identify IgM and IgG antibodies to SARS-CoV-2. Research has shown that after infection with SARS-CoV-2, viral antigens stimulate the body’s immune system to produce antibodies that can be detected with IgM and IgG tests.
The assays will be designed for use on any of Beckman Coulter’s high-throughput Access family of immunoassay systems, including the Access 2 and DxI series, which can be found worldwide.
“Antibody assays play a critical role in understanding the level of immunity an individual has developed against SARS-CoV-2,” said Kathleen Orland, Senior Vice President and General Manager for Beckman Coulter’s Chemistry and Immunoassay Business. “This type of understanding could help identify those who would require a vaccine, once available, or when an infected individual could safely return to work.”
Shamiram R. Feinglass, MD, MPH, Chief Medical Officer, Beckman Coulter, added: “With the ability to assess a patient’s immunity to SARS-CoV-2, this testing modality may enable clinicians to clear hospital staff, emergency responders, and others to get back to work with an indication that they have had prior exposure and therefore have built an immunity to the disease. This test could allow those without immunity to be identified and kept safe until the pandemic subsides.”
Beckman Coulter operates within the Danaher Corporation, together with a collection of the world’s leading diagnostic companies, all on the front line in the fight against coronavirus.
Once the assays are finalized, Beckman Coulter intends to achieve CE mark certification and to follow FDA’s Emergency Use Notification process.
For the latest information on the new assays, visit www.beckmancoulter.com/coronavirus
Sartorius supports development of vaccine candidate against SARS-COV-2 to enter clinical trials
, /in E-News /by 3wmediaSartorius, a leading international partner of life science research and the biopharmaceutical industry, has supported CanSino Biologics Inc. (“CanSinoBIO”) and Maj. Gen. Chen Wei’s team at the Institute of Bioengineering at the Academy of Military Medical Sciences (“Institute of Bioengineering”) in China in their development of the first vaccine candidate against the novel coronavirus SARS-CoV-2 to enter clinical trials. CanSinoBIO and the Institute of Bioengineering used Sartorius’ BIOSTAT® STR single-use bioreactor system for the upstream preparation of the recombinant vaccine, thus ensuring the rapid linear amplification of the adenovirus vector (Ad5-nCoV) and ultimately saving time during development.
The BIOSTAT® STR single-use bioreactor system comes with updated BioPAT® toolbox for process monitoring, as well as Flexsafe® STR integrated, single-use bioprocess bags. It has been proven to be used for vaccine manufacturing because it offers rapid scalability and flexibility to adapt to fluctuating demand. The single use bags prevent cross-contamination, and reduce the time needed for washing and sanitation typical in stainless steel bioreactors. As such, the amount of time needed to prepare a vector for a vaccine is shortened from several months to (several) weeks.
“We are pleased that we can help our clients and partners accelerate vaccine development while maintaining compliance with safety protocols, thereby allowing us to contribute to better health for more people,” said Huang Xian, Head of Marketing at Sartorius BPS China.
This is the second collaboration from Sartorius, CanSinoBIO, and the Institute of Bioengineering to accelerate vaccine development. In October 2017, Sartorius’ BIOSTAT® STR50 bioreactor system was used during CanSinoBIO’s and the Institute of Bioengineering’s joint development of a recombinant vaccine against Ebola virus disease. This was the first registered Ebola vaccine in the world.
Cobra Biologics and the Karolinska Institutet collaborate to develop COVID-19 vaccine
, /in Corona News, E-News /by 3wmediaCobra 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.”
Nova Biomedical to Host Webinar on COVID-19 Bedside Glucose Management
, /in Corona News, E-News /by 3wmediaWaltham, 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
Pharming Ruconest
, /in Corona News, E-News /by 3wmediaThe 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.
Roche to launched COVID-19 antibody test in early May
, /in Corona News, E-News /by 3wmediaRoche 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.”
Oxford companies join forces to scale up production of Covid-19 reagents
, /in Corona News, E-News /by 3wmediaOXGENE 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/
Horizon Discovery releases CRISPR screening for primary human B cells
, /in Corona News, E-News /by 3wmediaCambridge, UK-based Horizon Discovery Group, specializing in the application of gene editing and gene modulation for cell line engineering, has released an arrayed CRISPR knockout screening service for primary human B cells to its cell-based screening services.
The new B cell screening service, the first of its kind in the market, will enable researchers to identify genes that affect the function of B cells and examine how this impacts other immune cell types, particularly in infectious diseases, cancer, and auto-immune disorders, such as COVID-19, Burkitt’s lymphoma and multiple sclerosis respectively.
Primary human cells – cells that are freshly isolated from donors – are known to be difficult to study in the lab. However, working with these cells brings scientists one step closer to healthy or diseased micro-environments, enabling them to better understand disease etiology and therapeutic mechanisms, and thereby advance drug discovery and development programs.
“The interest in harnessing the immune system for effective therapies continues to grow, with the global cell therapy market predicted to reach $8.21bn by 2025. Expanding our services to encompass screening of both primary T and B cells is another example of our commitment to apply decades of gene editing experience in support of drug discovery and development for the treatment of human disease,” said Terry Pizzie, CEO, Horizon Discovery.
Dolomite and Mologic collaborate to scale-up manufacture of nanoparticles for Covid-19 diagnostic tests
, /in Corona News, E-News /by 3wmediaAs the COVID-19 pandemic progresses in countries around the globe, there is an urgent need for rapid and reliable point-of-need detection testing. Dolomite Microfluidics and Mologic are working together to accelerate the development and launch of these tests.
UK-based Mologic is a leading developer of rapid response diagnostic tests for diseases such as malaria and Ebola virus disease. Clients include the Bill & Melinda Gates Foundation, where Mologic is leveraging its core technology through its Centre for Advanced Rapid Diagnostics (CARD) to develop the next generation of ultra-sensitive point-of-care diagnostics which are easy to use andinexpensive to manufacture – critical to the success of many global health programmes. Most recently, Mologic has received UK Government funding to develop and manufacture a high sensitivity test for COVID-19 that generates results within minutes – rather than hours or days – without the need for a laboratory or specialist equipment.
The technology behind these tests involves the use of precisely manufactured nanoparticles. Dolomite specialises in equipment that allows the development and scale-up of precision nanoparticles. This is achieved by using microfluidic technology to retain advanced control of production conditions. Dolomite is working with Mologic to combine ground-breaking diagnostic technology with continuous flow microfluidic manufacturing processes to accelerate the validation and release of Mologic’s COVID-19 diagnostic test.