Free Webinar | Multiplex Serological Assays for COVID-19

Recorded May 27, 2020 | 1:00-2:00 pm EDT

Chairperson: Rob Burgess, PhD, Chief Business Officer, Sino Biological

1:00 Application of SARS-CoV-2 Serological Assays for Monitoring the Epidemic and Qualification of Donors and Plasma for Use as COVID-19 Convalescent Plasma (CCP)

Michael P. Busch, MD, PhD, Director, Vitalant Research Institute; Senior Vice President for Research and Scientific Programs, Vitalant; Professor of Laboratory Medicine, University of California, San Francisco

Vitalant Research Institute (VRI) has developed and is driving two large studies related to SARS-CoV-2/COVID-19. One study, funded by the NHLBI and NIAID, is titled RESPONSE (REDS Epidemiology, Surveillance and Preparedness of the Novel SARS-CoV-2 Epidemic). The RESPONSE study will evaluate the rates of SARS-CoV-2 RNA in 300,000 donations in minipools and SARS-CoV-2 Abs 36,000 donations in 6 US blood collection regions. It will also track rates of COVID-19 post-donation information (PDI) reports with donation plasma tested for RNA, recipients tested to investigate potential transfusion transmission, as well as 150 PDI donors with infection followed for 12 months with collection of longitudinal serum and PMBC samples for characterization of immune responses over time and to establish a sharable repository for pathogenesis and vaccine research. In addition, we are leading a large CDC-funded national serosurvey to apply SARS-CoV-2 Ab assays to test 340,000 blood donor samples collected in monthly serial cross-sectional waves in 25 regions within the US. This study will also follow 150 convalescent plasma donors for 18 months with characterization of SARS-CoV-2 antibody dynamics over time using multiple high-throughput platforms, a novel pseudotyped SARS-CoV-2 reporter viral particle neutralizing assay to perform high-throughput titration to qualify COVID-19 Convalescent Plasma (CCP), and a respiratory viral protein array assay developed by Dr. Philip Felgner’s team at UC Irvine in partnership with Sino Biological.

1:20 Optimized Development of Pathogen Inactivated COVID-19 Convalescent Plasma

Laurence M. Corash, MD, Co-Founder & CSO, Cerus

COVID-19 is a highly contagious and morbid infectious disease resulting in severe pulmonary injury caused by a novel emerging respiratory pathogen, SARS-CoV-2. Currently there are limited therapeutic options and limited resources for support of patients with COVID-19 acute respiratory failure – the major cause of death. Transfusion of plasma containing neutralizing antibodies (Ab) to SARS-CoV-2 from asymptomatic or convalescent COVID-19 donors is a potential near-term therapeutic option to prevent or mitigate tissue injury provided that these antibodies effectively neutralize SARS-CoV-2 infection and do not cause antibody dependent COVID-19 enhancement. Prior experience with immune plasma therapy has shown reduced mortality of Argentine Hemorrhagic Fever and reduced time to hospital discharge for SARS. Therapeutic convalescent plasma (CP) with amotosalen-UVA pathogen inactivation (PI) treatment has been prepared from convalescent Ebola virus patients with retention of Ab neutralization efficacy; and safely transfused to acutely infected patients. PI treatment of CP is an important measure to mitigate risk of blood-borne pathogen transmission, especially since pooled donor plasma collections to enhance Ab diversity may be optimal for efficacy and these donors do not meet the criteria for qualified healthy blood donors. This approach is enabled by FDA licensure of amotosalen-UVA plasma including SARS CoV inactivation, and more than 10 years of clinical experience demonstrating safety and efficacy. The therapeutic efficacy of pathogen inactivated COVID-19 convalescent plasma will be optimized by characterization of antibody titers and epitope profiles.

1:40 Analysis of SARS-CoV-2 Antibodies in COVID-19 Convalescent Plasma Using a Coronavirus Antigen Microarray

Philip Felgner, PhD, Director, Protein Microarray Laboratory, Infectious Diseases, School of Medicine, University of California, Irvine

The current practice for diagnosis of COVID-19, based on SARS-CoV-2 PCR testing of pharyngeal or respiratory specimens in a symptomatic patient at high epidemiologic risk, likely underestimates the true prevalence of infection. Serologic methods can more accurately estimate the disease burden by detecting infections missed by the limited testing performed to date. Here, we describe the validation of a coronavirus antigen microarray containing immunologically significant antigens from SARS-CoV-2, in addition to SARS-CoV, MERS-CoV, common human coronavirus strains, and other common respiratory viruses. A comparison of antibody profiles detected on the array from control sera collected prior to the SARS-CoV-2 pandemic versus convalescent blood specimens from virologically confirmed COVID-19 cases demonstrates complete discrimination of these two groups. This array can be used as a diagnostic tool, as an epidemiologic tool to more accurately estimate the disease burden of COVID-19, and as a research tool to correlate antibody responses with clinical outcomes.

Speaker Biographies

Rob Burgess, PhD
Chief Business Officer, Sino Biological

Dr. Rob Burgess is currently Chief Business Officer at Sino Biological, Inc. and has over 25 years of scientific and business development experience. His previous positions include Vice President, Global Business Development at RayBiotech; Vice President, Business Development for the U.K.-based firm Stem Cell Sciences; Vice President, Research and Development at the nanotechnology company Zyvex Corporation; Director of Scientific Sourcing and New Technologies for the bio-reagent and services company Serologicals Corporation; and Senior Director, Functional Genomics and Corporate Business Development for the Serologicals subsidiary Chemicon International. In addition, he has published in major scientific journals including Nature and Science on a variety of research in genetic engineering, developmental biology, and the molecular control of cellular identity. He has received numerous awards including appointment to the Governor’s Blue-Ribbon Steering Committee for the Southern California Life Sciences Summit and Visiting Scholar at Georgia Tech University. He has also authored two college textbooks: "Understanding Nanomedicine: An Introductory Textbook" available from Pan Stanford Publishing and “Stem Cells: A Short Course” available from Wiley-Blackwell. Dr. Burgess holds a BA in biochemistry from the University of Texas at Austin and a PhD in molecular biology from the University of Texas, MD Anderson Cancer Center in Houston. 

Michael P. Busch, MD, PhD
Director, Vitalant Research Institute; Senior Vice President for Research and Scientific Programs, Vitalant; Professor of Laboratory Medicine, University of California, San Francisco

Dr. Michael Busch earned his MD and PhD degrees at the University of Southern California followed by residency training in Pathology, Laboratory Medicine and Transfusion Medicine at the University of California, San Francisco (UCSF). He is currently Director of Vitalant Research Institute (BSRI) and Senior Vice President for Research and Scientific Affairs at Vitalant, a national network of blood centers and donor testing laboratories. He is also a Professor of Laboratory Medicine at UCSF. Dr. Busch’s major research interests include:  1) The epidemiology, pathogenesis, and laboratory evaluation of transfusion-associated viral infections, including HIV-1/2, HTLV-I/II, HBV, and HCV, as well as blood safety implications of new and emerging transfusion-transmissible infectious diseases (e.g., Zika virus, West Nile virus, Dengue virus, Chikungunya virus, T. cruzi, Babesia, etc.);  2)  Development and implementation of new or improved laboratory assays and blood donor screening protocols, clinical evaluation and management, and possible prevention by pathogen inactivation of blood-borne infections, with particular focus on new techniques for mass screening of blood donations using nucleic acid amplification technology (NAT) to reduce the infectious window period and detect new and emerging infectious diseases; 3) Mechanisms and prevention of immunological consequences of transfusions, including transfusion-induced immune modulation, viral reactivation, microchimerism, graft-vs-host disease, transfusion-related acute lung injury and alloimmunization; and 4) Mechanisms of HIV persistence and development, validation and application of novel assays to quantify HIV reservoirs in HIV-suppressed subjects in the context of cure research interventions. Dr. Busch has published ~500 peer-reviewed original scientific articles and over 150 review articles, editorials, and book chapters.

Laurence M. Corash, MD
Co-Founder & CSO, Cerus

Laurence Corash, MD is Senior Vice President and Chief Scientific Officer of Cerus Corporation, which he founded in 1992. He is Professor of Laboratory Medicine at the University of California, San Francisco, where he served for 15 years as Chief of the Clinical Laboratory Hematology Service. He has published 192 original research papers in peer reviewed journals in the field of hematology and transfusion medicine. Dr. Corash graduated from New York University School of Medicine and completed Internal Medicine training at Bellevue Hospital, New York, NY. He was a Research Associate at the National Institute of Child Health and Human Development (NICHD), Bethesda, MD (1971-73) and completed training in Hematology and Hematology-Pathology at the National Institutes of Health (NIH), Clinical Center. From 1977 to 1981 he served as Assistant Chief, Hematology Service at the NIH Clinical Center. He is Board Certified in Medicine, Hematology, and Hematology-Pathology. Dr. Corash has collaborated with scientists in academic institutions and government agencies throughout the US and abroad, as well as colleagues at Cerus on research in blood cell aging and technology for inactivation of infectious pathogens in blood components, and has directed the development of technology for the inactivation of pathogens in labile blood components. Currently, he is the Principal Investigator of a contract from the US Department of Health and Human Services to complete development of the INTERCEPT Blood System for Red Blood Cells. He also leads the Convalescent Plasma for Emerging Pathogens Consortium to develop convalescent plasma for the COVID-19 pandemic. The INTERCEPT pathogen inactivation system for preparation of platelets and plasma he developed is in use by more than 200 blood centers around the world.

Philip Felgner, PhD
Director, Protein Microarray Laboratory, Infectious Diseases, School of Medicine, University of California, Irvine

Dr. Felgner is Director of the UCI Vaccine Research and Development Center and the Protein Microarray Laboratory and Training Facility. The goal of his current research is to identify the right antigens to use for vaccines. The Laboratory developed a high throughput approach to clone and express all proteins encoded in a microorganism’s genomic DNA and print them onto protein microarrays. The Lab has cloned 70,000 genes derived from 35 infectious microorganisms, expressed and printed the encoded proteins on microarrays and probed with an inventory of more than 25,000 sera from infected, vaccinated, and healthy people worldwide to identify serodiagnostic and vaccine antigens. Dr. Felgner joined the faculty at UC Irvine in 2002 after two decades of experience in the biotechnology industry, including founding Vical, Inc. in San Diego based on his discovery of DNA vaccines and serving as Chief Scientific Officer to help build the company into a publicly traded entity. He discovered and developed ‘Lipofection’ DNA transfection technology in 1985, the most widely used approach for introducing nucleic acid into cultured cells. His work has led to 200 published papers and 45 patents that have been cited by other scientists more than 33,000 times, and founding of a UCI startup company Antigen Discovery, Inc.