The emergence of the COVID-19 pandemic resulting from the spread of the SARS-CoV-2 virus has ignited high-priority and compressed timeline efforts for the development of COVID-19 vaccines, therapeutics, and diagnostic tests for viral infections and antibody responses. These time-critical efforts have also put into focus the need for better approaches for vaccine bioanalysis to keep step with these rapidly developing efforts.
Maximizing immunoassay speed (time to results), assay performance, and reproducibility are even more important in the COVID-19 pandemic response. Immunoassays for quantifying COVID-19 antibodies in serum, bioanalysis of antibody-based therapeutics, and bioanalysis during vaccine development and bioprocessing must increase productivity and data quality, and help meet aggressive project timelines in the pandemic response.
Solutions for meeting these pandemic-related immunoassay performance goals can be realized using Gyrolab® immunoassay platform.
The detection of antibodies to SARS-CoV-2 in human serum with serology assays is a necessity for understanding SARS-CoV-2 immune responses, measuring its impact on public health, and for developing effective vaccines and therapeutics. To meet this ongoing need, a three-step bridging Gyrolab SARS-CoV-2 antibody immunoassay is now available. This assay has a broad dynamic range for qualitative detection of total antibodies generated against the receptor binding domain (RBD) of the spike (S) protein of SARS-CoV-2 in human serum samples.1
Cross-sectional model of coronavirus
The RBD of the S protein is directly involved in SARS-CoV binding to the human angiotensin-converting enzyme 2 (ACE2) receptor for entry into host cells and is an active target for vaccine and therapeutics development.
The three-step bridging Gyrolab SARS-CoV-2 antibody immunoassay utilizes a Gyrolab Bioaffy™ CD. The method encompasses a biotinylated SARS-CoV-2, Spike RBD-His recombinant protein as the capture molecule, and SARS‑CoV-2 Spike RBD-Fc recombinant protein labeled with Alexa Fluor® 647 as the detection molecule. This assay detects IgG, IgA and IgM antibody subtypes within the human serum.
A series of standard samples was prepared to determine the immunoassay dynamic range. The assay dynamic range is 40 ng/mL to 200 µg/mL.
Average responses obtained for a negative control (NC) and positive controls ranging from 40 ng/mL to 200 µg/mL (in neat serum) in Rexxip H containing 25% human serum. Rabbit polyclonal anti-SARS-CoV-2 Spike RBD antibody was used as positive control.
Bioanalysis during vaccine development presents many challenges in diversity of assay complexity, sample matrices, analyte types, and demands on workflow efficiency. There is an additional demand for rapid data generation as project timelines for COVID-19 vaccine development are routinely compressed to shorten development time with the goal to combat the pandemic.
Maximizing immunoassay speed is accomplished with Gyrolab platform, since the long incubation times for manual ELISAs are eliminated.
Customer example of improvements in analysis time, dynamic range, sample savings, and assay development time when transitioning from ELISA to Gyrolab immunoassay.
Immunoassays are used in vaccine development to characterize vaccine titer, purity, affinity, and potency, as well as their immunogenic response in both animals and humans. Gyrolab assay flexibility allows running multiple assays on a single Gyrolab Bioaffy CD as in the example below.
Immunogenicity responses in a preclinical mouse study detecting IgG antibody subtypes simultaneously in a single run were analyzed with Gyrolab immunoassays to screen responses from different formulations.
Read the Spin Blog posts to learn about better tools for vaccine bioanalysis:
Download the Application Note, Gyrolab Immunoassays to support vaccine development and production
Gyrolab PK immunoassays for COVID-19 antibody therapeutics
The repurposing of currently approved antibody therapeutics for COVID-19 is an intense area of interest, since approved drugs have already been shown to be safe in humans and clinical trial timelines are dramatically shortened to reach patients. One target for treatment is the prevention of cytokine storms that can lead to acute respiratory distress syndrome (ARDS) in COVID-19 patients.
Cytokine storms, or high-level immune responses with the rapid release of inflammatory cytokines, is a possible mechanism for development of critical respiratory distress syndrome causing serious illness. Since IL-6 is one of the pro-inflammatory cytokines released, Actembra® (tocilizumab), an FDA-approved IL-6 inhibitor, is currently being evaluated in a Phase III clinical trial as a potential therapeutic intervention in hospitalized adult patients with severe COVID-19 pneumonia.
To accelerate immunoassay bioanalysis for IL-6 inhibitor development, a Gyrolab tocilizumab PK assay protocol is now available.
Download the Acterma (tocilizumab) PK Gyrolab assay protocol
For more information, Contact Us and one of our scientists would be glad to help you.