
Solutions for COVID-19 vaccine safety and immunogenicity evaluation
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Researchers around the world are working hard on a vaccine for COVID-19. Up until now, several vaccine candidates have entered into phase III clinical trials. Experts estimate that a fast-tracked vaccine development process could potentially bring a successful candidate to market within one year or even less. In the development of a COVID-19 vaccine, safety and immunogenicity evaluation are indispensable and well-established assays are required for fast and convenient assessment of the vaccine candidates.
Based on advanced technology platform in recombinant protein production, ACROBiosystems has developed a series of critical reagents for COVID-19 vaccine development and evaluation, including recombinant proteins, antibodies and ELISA kits. These featured products are suitable for IgG/M antibody titer detection, neutralizing antibody titer detection and antigen titer detection to accelerate the vaccine development.
Application
>>> Scenario 1: IgG antibody titer detection
>> Recommended products
Cat.No. SPN-C52H9
Products: SARS-CoV-2 S protein, His Tag, Super stable trimer (MALS & NS-EM verified)
· The purity, molecular weight and polymeric form were rigorously verified by SDS-PAGE, SEC-MALS and NS-EM.

Fig 1. The purity of SARS-CoV-2 S protein, His Tag, Super stable trimer (Cat. No. SPN-C52H9) was more than 90% verified by SDS-PAGE under reducing (R) condition. The molecular weight was around 550-660 kDa confirmed by SEC-MALS. The particles are similar in size and appearance to SARS-CoV-2 trimers reported in published literature verified by negative stain electron micrography.
· Bioactivity of binding to anti-SARS-CoV-2 neutralizing antibody was verified by ELISA

Fig 2. Immobilized Anti-SARS-CoV-2 Neutralizing Antibody, Human IgG1 (Cat. No. SAD-S35) at 1 μg/mL (100 μL/well) can bind SARS-CoV-2 S protein, His Tag, Super stable trimer (Cat. No. SPN-C52H9) with a linear range of 0.3-10 ng/mL
Cat.No. SPD-C82E9
Products: Biotinylated SARS-CoV-2 (COVID-19) S protein RBD, His,Avitag™ (MALS verified)
· Bioactivity of binding to anti-SARS-CoV-2 neutralizing antibody was verified by ELISA

Fig 3. Immobilized Biotinylated SARS-CoV-2 S protein RBD, His,Avitag (Cat. No. SPD-C82E9) at 1 μg/mL (100 μL/well) on Streptavidin (Cat. No. STN-N5116) precoated (0.5 μg/well) plate, can bind Monoclonal Anti-SARS-CoV-S protein RBD Antibody, Human IgG1 with a linear range of 0.1-4 ng/mL
>> Case Study:
Pfizer employed ACROBiosystems’ featured biotinylated S protein RBD in the RBD-binding IgG assay during the phase 1/2 research. The interim report showed that the biotinylated S protein RBD from ACROBiosystems (Cat.No. SPD-C82E9) was bound to streptavidin-coated Luminex microspheres.


Reference: Mulligan et al., (2020). Phase 1/2 Study to Describe the Safety and Immunogenicity of a COVID-19 RNA Vaccine Candidate (BNT162b1) in Adults 18 to 55 Years of Age: Interim Report. medRxiv, doi: http://life.acrobiosystems.cn/e/535472/10-1101-2020-06-30-20142570/2ltqp9b/1014932761?h=ZaZbs5vDDB1xvQSqFnCJ3Y8cvsX-JqYiElZkxBsY_NM
Cat.No. TAS-K002
Products: Anti-SARS-CoV-2 Antibody IgG Titer Serologic Assay kit (Spike protein RBD)

Fig 4. Immobilized SARS-CoV-2 S protein RBD at 2 μg/mL (100 μL/well) can bind Monoclonal Anti-SARS-CoV-2 Antibody, Human IgG1 in 1:50 human serum. Detection was performed using HRP-Conjugated Anti-human IgG antibody with sensitivity of 24 ng/mL
>>> Scenario 2: Neutralizing antibody titer detection
>> Recommended products
Cat.No. SPD-C52H3
Products:SARS-CoV-2 (COVID-19) S protein RBD, His Tag (MALS verified)
· Bioactivity of binding to anti-SARS-CoV-2 neutralizing antibody was verified by ELISA

Fig 5. Immobilized SARS-CoV-2 S protein RBD, His Tag (Cat. No. SPD-C52H3) at 1 μg/mL (100 μL/well) can bind Anti-SARS-CoV-2 RBD Neutralizing Antibody, Human IgG1 (Cat. No. SAD-S35) with a linear range of 0.1-3 ng/mL
· Bioactivity of binding to ACE-2 was verified by ELISA

Fig 6. Immobilized SARS-CoV-2 S protein RBD, His Tag (Cat. No. SPD-C52H3) at 1 μg/mL (100 μL/well) can bind Human ACE2, Fc Tag (Cat. No. AC2-H5257) with a linear range of 0.2-3 ng/mL
Cat.No. TAS-K003
Products: Anti-SARS-CoV-2 Neutralizing Antibody Titer Serologic Assay kit

Fig 7. Neutralizing titer of Anti-SARS-CoV-2 Neutralizing Antibody, Human IgG1 (Cat.No.SAD-S35) measured by Anti-SARS-CoV-2 neutralizing antibody titer serologic assay kit (Cat. No. TAS-K003).
>>> Scenario 3: Antigen titer detection
>> Recommended products
Cat.No. TAS-K011
Products: SARS-CoV-2 Spike Protein Titer Assay Kit

Fig 8. Immobilized Anti-SARS-CoV-2 Spike S1 Antibody at 2 μg/mL (100 μL/well) can bind SARS-CoV-2 Spike Protein. And then add Biotinylated Anti-SARS-CoV-2 Spike S1 Antibody at 1ug/ml. Detection was performed using HRP-conjugated streptavidin with sensitivity of 24 pg/mL
Product List
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