코로나19의 잠재적 치료법을 개발하기 위해 SARS-COV-2 바이러스를 이해하고자 전 세계적으로 연구 활동에 집중하고 있습니다. Join us as we explore a scientific timeline of key COVID-19 discoveries. The infographic highlights the historic development in diagnostics, vaccines, and therapeutic antibodies. We’ll share our workflow solutions to the challenges of diagnosis, treatment, and prevention offering key systems to help accelerate your COVID-19 research and time to market.

1. Diagnostic development: The commercialization of the first COVID PCR test

The SARS-CoV-2 virus, the causative agent for COVID-19 and the worst pandemic in modern history, was first identified in isolated cases in late 2019. The genetic sequence of the virus was obtained in early 2020 and subsequently shared with research laboratories around the world. The race to understand the molecular underpinnings of the virus and to develop effective treatments and vaccines was underway.

• January 2020 – SARS-CoV-2 was cultured in the lab for the first time for the purposes of research. This was a critical early piece of the puzzle for the development of diagnostic tests and vaccines.\
• February – March 2020 – Numerous genetic tests based on PCR, ELISA, and other techniques arose to meet the challenges of determining positive cases of viral infection and combating the spread of the disease.\
• April 2020 – Eighteen Laboratory Developed Tests (LDTs) had achieved Emergency Use Authorization (EUA) from the FDA, a number that would double within one month.\
• September 2020 – The number of EUA diagnostic tests reached in excess of 250, including over 200 molecular tests, 50 antibody tests, and multiple antigen-based tests. Such tests covered the lifecycle of viral infection from early detection of virus in the case of molecular and antigen tests, to immune responses measure by host antibody detection.

Process of diagnostic development using ELISA

The process of diagnostic development can involve multiple steps in identifying biomarkers indicative of virus. These include**** genetic signatures in the case of RT-PCR, or viral antigens in the case of antigen-based detection. Viral antigen and host antibody detection can be achieved by the use of enzyme-linked immunoassay (ELISA) and other quantitative approaches. Early characterization is paramount to understanding key targets for which tests and assays will eventually be developed.

The above workflow for a typical sandwich ELISA procedure is time-consuming and labor-intensive; a laboratory automation for a high-throughput ELISA workflow can help with providing walkaway time, increasing throughput, effectiveness and efficiency of the assay procedure, and reproducibility.

The SpectraMax ABS and ABS Plus absorbance microplate readers provide the flexibility, sensitivity, and convenience for a wide range of assays such as ELISAs, microbial growth, and protein quantitation.

The SpectraMax® iD3 and iD5 Multi-Mode Microplate Readers measure absorbance, fluorescence, and luminescence. In addition, the iD5 reader measures TRF and FP and can be expanded to include TR-FRET, HTRF®, BRET, dual-luciferase reporter assays with injectors, and western blot detection.

The SpectraMax® i3x Multi-Mode Microplate Reader measures absorbance, fluorescence, and luminescence with available upgrades including western blot, cell imaging, and fast kinetics with injectors, plus additional detection modes.

AquaMax® Microplate Washer는 96 및 384 well Microplate에 대해 원하는 대로 구성할 수 있으며, 자체적으로 독립적인 솔루션입니다.

2. Vaccine development: The global effort to expedite COVID vaccines

On another front, a massive campaign was being waged in the development of vaccines to prevent SARS-CoV-2 infection and spread. Based on years of previous exploratory and preclinical work, several companies harnessed the genetic sequence of the virus in the creation of novel mRNA-based vaccines. Other routes of vaccine development were being explored as well, including those based on viral vector delivery systems and more traditional delivery of killed or attenuated viral particles. A multi-pronged approach was key to elucidating the most effective prevention strategies.

• April 2020 – Both Moderna and Pfizer had completed preclinical research and development of mRNA vaccine candidates. Johnson & Johnson and Astra Zeneca pursued clinical trials of their vaccine candidates in the ensuing weeks. These efforts were frontrunners in a wave of vaccine development, with over 80 vaccine candidates under development and at least five entering Phase 1 clinical testing around that time.\
• April 2020 – The Moderna vaccine candidate reached a milestone by transitioning into the second round of dosing.\
• May 2020 – Moderna received FDA clearance to advance into Phase II trials.\
• June 2020 – The number of vaccines in development had climbed to over 130, with 16 in clinical trials.\
• July 2020 – The Moderna Phase III clinical trial commenced.\
• December 2020 – The Moderna vaccine was granted Emergency Use Authorization by the FDA, quickly followed by EUA approvals for the Pfizer BioNTech and Johnson & Johnson vaccines.\
• May 2021 – The global community reached the major milestone of 1 billion COVID-19 vaccinations. This staggering accomplishment came a mere 4 months after vaccine rollout and just over a year after vaccine trials in humans began.

Solutions for antigen and immunogen discovery for vaccine development

Vaccine development hinges on the initial understanding of viral DNA, antigens, and immunogenic response by the host immune system. In vaccine research, immunogen assays are used in viral screens, followed by extensive characterization of positive immunogenic genes and proteins. These can then be engineered and optimized to facilitate downstream vaccine development efforts. Key steps in the process include the use of tools for screening and identification of positive cell clones.

https://share.vidyard.com/watch/VMz74R2JyixorrzhW1Pank

이 동영상에서는 BioPharma 플랫폼의 관리자인 Justin Dranschak이 재조합 단백질을 면역원으로 사용한 우리의 백신 개발 실험과정 솔루션을 검토하고 연구를 보조할 수 있는 시스템을 참고자료로 제시합니다.

QPix® 400 Series Microbial Colony Pickers allow you to fully automate synthetic biology workflows for DNA assembly, antibody discovery, and protein engineering. QPix 소프트웨어는 다양한 데이터 추적 및 assay 도구를 이용하여 복잡하고 반복적인 과정의 제어 및 관리를 간소화합니다.

The CloneSelect™ Single-Cell Printer™ (SCP) is a fully automated system that utilizes proprietary microfluidics-based technology and real-time image analysis to sort and deposit single cells into standard microplates—while simultaneously providing assurance of monoclonality through image documentation.

The SpectraMax® i3x Multi-Mode Microplate Reader measures absorbance, fluorescence, and luminescence with available upgrades including western blot, cell imaging, and fast kinetics with injectors, plus additional detection modes.

Our ImageXpress High-content Imaging Systems offer an end-to-end solution for high-content screening and analysis. 모든 시스템은 광범위한 응용 분야, 다량샘플 처리량, 간소화된 워크플로우를 지원합니다.

3. Antibody discovery: The race to develop and scale therapeutic antibodies

Although vaccine development efforts target the prevention of viral infection and spread, the advent of therapeutics to treat disease are equally important. The development of therapeutic monoclonal antibodies has played a critical role in bolstering the immune system and assisting patients afflicted with COVID-19. The process depends on identification and characterization of antibodies, protein engineering, and selection and growth of positive hybridoma cell lines.

• April 2020 – There were over 150 drugs under development for treating COVID-19, many of which had been previously approved for other viral infections and were indicated as safe for human use. At this time, according to the World Health Organization, there were over 1,000 ongoing clinical studies of treatments for COVID-19, many of which involved therapeutic antibodies.\
• May 2020 – Phase II and III clinical trials were pursued for the novel fully human poly-clonal antibody therapeutic SAB-185, developed by SAB Biotherapeutics.\
• July 2020 – Regeneron entered phase III clinical trials for a fully-humanized antibody cocktail REGN-COV2, containing two antibodies that bind non-competitively to the receptor binding domain of the virus’s spike (S) protein. This arrangement decreases the ability of mutant viruses to avoid treatment and protects against spike variants that have evolved in the human population.\
• September 2020 – Data from the phase III trial for the REGN-COV2 antibody cocktail was shown to reduce viral loads and improve the systems of non-hospitalized COVID-19 patients.\
• December 2020 – The FDA issued its first emergency use authorization for a COVID-19 antibody treatment. Bamlanivimab (from Eli Lilly) uses artificially engineered antibodies based on those isolated from people who have recovered from the disease, or convalescent patients.\
• May 2021 – With FDA EUA approval for the novel antibody Sotrovimab, companies began designing next-generation antibodies modeled on those taken from unique individuals whose immune systems can neutralize SARS-CoV-2, including any novel variants that may arise.

대규모 항체 라이브러리의 Hybridoma 생성과 Screening

Hybridoma technology is a method for mass-producing antibodies in a hybrid cell line generated from the fusion of antibody-producing B-cells with an immortalized myeloma cell line, called a hybridoma cell. Since every B-cell produces a unique antibody, single-cell cloning of hybridomas can be used to generate a diverse library of unique monoclonal antibodies at a large scale, which is frequently used in the prevention, diagnosis, and treatment of disease.

The video below presents our solution for a hybridoma workflow and references the systems to aid in your research.

https://share.vidyard.com/watch/XT7k1HMuRMAyrUUh5S75A774R2JyixorrzhW1Pank

Justin Dranschack, manager of BioPharma solutions at Molecular Devices, discusses the hybridoma mAbs workflow and highlights automated systems that accelerate time to market.

The CloneSelect® Imager can help you meet regulatory demands of single cell verification with its automated analysis of cells in the white light channel and optional fluorescence to add another layer of confidence to monoclonality verification. The system also enables concurrent confluence and monoclonality studies.

The ClonePix® 2 Mammalian Colony Picker is a fully automated system for the selection of high-value clones used in antibody discovery and cell line development. Available with optional monoclonality assurance feature to condense cell line development workflows to a single instrument.

The SpectraMax® iD3 and iD5 Multi-Mode Microplate Readers measure absorbance, fluorescence, and luminescence. iD5 Reader는 추가로 TRF 및 FP를 측정하며 TR-FRET, HTRF®, BRET, Injector를 활용한 Dual Luciferase REporter Assay 및 Western blot 등의 활용으로 확장이 가능합니다.

Our ImageXpress High-content Imaging Systems offer an end-to-end solution for high-content screening and analysis. 모든 시스템은 광범위한 응용 분야, 다량샘플 처리량, 간소화된 워크플로우를 지원합니다.

4. How to accelerate your COVID-19 research

Vaccine development workflows vary depending upon the platform (e.g., inactivated virus vs. DNA vaccine) chosen, each having its own advantages. To increase the likelihood of success against the infectious agent, CEPI, the Coalition for Epidemic Preparedness Innovations, and many other organizations promote diverse approaches during a pandemic.

We’ve created a variety of virus-related workflows – from antigen/immunogen and antibody discovery to stable cell line development. Above is a general workflow for vaccine development using recombinant proteins as the immunogen, referencing automated instrumentation to accelerate your research.

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