GeneMedi Efficacy Assay/Evaluation Solutions for COVID-19 Vaccines and Therapeutic antibodies against SARS-CoV2(2019nCoV)

To meet accumulated mutating of SARS-CoV-2, GeneMedi keeps continually developing novel solutions and tools for efficacy evaluation of COVID-19 vaccines (and neutralized antibodies) against novel mutant SARS-CoV-2 (2019nCoV) lineages. Our scientist's team takes duty in fighting against the COVID-19 pandemic with our global industrial and academic partners.

1. GeneMedi information and products collection of SARS-COV-2 (2019nCOV) UK B.1.1.7 lineage and South Africa 501Y.V2 lineage and Brazilian P.1 lineage(B.1.1.28.1)

Background Reading: Information and products collection of SARS-COV-2 (2019nCOV) UK B.1.1.7 lineage Information and products collection of SARS-COV-2 (2019nCOV) South Africa 501Y.V2 lineage information and products collection of SARS-COV-2 (2019nCOV) Brazilian P.1 lineage (B.1.1.28.1)

GeneMedi pseudotyped virus (pseudovirus) of SARS-COV-2 (2019nCOV) B.1.1.7 lineage

GeneMedi pseudotyped virus (pseudovirus) of SARS-COV-2 (2019nCOV) 501Y.V2 lineage

GeneMedi pseudotype virus (pseudovirus) of SARS-COV-2 (2019nCOV) P.1 lineage(B.1.1.28.1, Brazilian variant)

SARS-COV-2 (2019nCOV) B.1.1.7 lineage & 501Y.V2 lineage(B.1.351) & P.1 lineage (B.1.1.28.1, Brazilian variant) of Spike protein & ACE2 competition binding assay for efficacy evaluation of COVID-19 vaccines and therapeutic antibodies

GeneMedi codon-optimized spike mammalian expression vector for SARS-COV-2 (2019nCOV) B.1.1.7 lineage

GeneMedi codon-optimized spike mammalian expression vector for SARS-COV-2 (2019nCOV) South Africa 501Y.V2 lineage(B.1.351).

GeneMedi codon-optimized spike mammalian expression vector for SARS-COV-2 (2019nCOV) - P.1 lineage(B.1.1.28.1, Brazilian variant)

2. Multiple variants of Spike protein & ACE2 competition binding assay for efficacy evaluation of COVID-19 vaccines and therapeutic antibodies

The Spike proteins variants that GeneMedi offer is including:

1) Multiple variants of recombinant Spike protein for Spike protein & ACE2 competition binding assay for efficacy evaluation of COVID-19 vaccines and therapeutic antibodies

2) Recombinant human ACE2 protein products

Cat No.	Antigen Name of 2019-nCoV(SARS-CoV-2)	Isotypes	Order
GMP-H-ACE2001	Recombinant human solubale ACE2 protein (soluble hACE2, extracellular hACE2, C-His)	Mammalian (human cell)
GMP-H-ACE2002	Recombinant human solubale ACE2 protein (soluble hACE2, extracellular hACE2, C-His)	Mammalian (human cell)

- Competition assay for neutralizing antibodies, peptides inhibitor and vaccines-immunized serums

3. Multi-Variants™ SARS-CoV2 (wildtype, D614G, N501Y, E484K, B.1.1.7 lineage, 501Y.V2 lineage, and so on) Pseudotype virus-Based Neutralization Assay System for efficacy evaluation of COVID-19 vaccines and therapeutic antibodies (Lentiviral pseudovirus)

Protocol: GeneMedi SARS-CoV2 pseudovirus-based neutralization assay-protocol        Protocol Download

4. Codon-optimized mammalian expression vector for SARS-COV-2 (2019nCOV) spike wide type & mutant variants (D614G, N501Y, E484K, B.1.1.7 lineage, 501Y.V2 lineage, and so on)

Cat No.	Gene &Vector description of 2019 nCoV	Vector	Order
GMV-V-2019nCoV-017	pGM-2019nCoV-spike protein (S protein,S1+S2)	pcDNA3.1(+)
GMV-V-2019nCoV-008	pGM-2019nCoV-spike protein (S protein,S1+S2)	pcDNA3.1(+)
GMV-V-2019nCoV-054	pGM-2019nCoV-spike D614G protein (S protein,S1+S2，D614G)	pcDNA3.1(+)
GMV-V-2019nCoV-057	pGM-2019nCoV-spike S943P protein (S protein,S1+S2，S943P)	pcDNA3.1(+)
GMV-V-2019nCoV-058	pGM-2019nCoV-spike V367F protein (S protein,S1+S2，V367F)	pcDNA3.1(+)
GMV-V-2019nCoV-059	pGM-2019nCoV-spike G476S protein (S protein,S1+S2，G476S)	pcDNA3.1(+)
GMV-V-2019nCoV-060	pGM-2019nCoV-spike V483A protein (S protein,S1+S2，V483A)	pcDNA3.1(+)
GMV-V-2019nCoV-061	pGM-2019nCoV-spike H49Y protein (S protein,S1+S2，H49Y)	pcDNA3.1(+)
GMV-V-2019nCoV-062	pGM-2019nCoV-spike Q239K protein (S protein,S1+S2，Q239K)	pcDNA3.1(+)
GMV-V-2019nCoV-063	pGM-2019nCoV-spike A831V protein (S protein,S1+S2，A831V)	pcDNA3.1(+)
GMV-V-2019nCoV-064	pGM-2019nCoV-spike P1263L protein (S protein,S1+S2，P1263L)	pcDNA3.1(+)
GMV-V-2019nCoV-065	pGM-2019nCoV-spike D839Y/N/E-D839Y protein (S protein,S1+S2，D839Y/N/E-D839Y)	pcDNA3.1(+)
GMV-V-2019nCoV-066	pGM-2019nCoV-spike D839Y/N/E-D839N protein (S protein,S1+S2，D839Y/N/E-D839N )	pcDNA3.1(+)
GMV-V-2019nCoV-067	pGM-2019nCoV-spike D839Y/N/E-D839E protein (S protein,S1+S2，D839Y/N/E-D839E)	pcDNA3.1(+)
GMV-V-2019nCoV-099	pGM-2019nCoV-Spike trimer ( P2-mutant,S1/S2 cleavage site（furin cleavage sequence)-mutant,trimerization modified)	pcDNA3.1(+)
GMV-V-2019nCoV-100	pGM-Spike of SARS-COV-2 B.1.1.7 lineage whole mutation	pcDNA3.1(+)
GMV-V-2019nCoV-101	pGM-2019nCoV-Spike(S1+S2)-RBD N501Y mutation(B.1.1.7 lineage RBD)	pcDNA3.1(+)
GMV-V-2019nCoV-102	pGM-2019nCoV-Spike(S1+S2)-S1 HV 69-70 Deletion mutation(ΔH69/ΔV70,B.1.1.7 lineage)	pcDNA3.1(+)
GMV-V-2019nCoV-107	pGM-2019nCoV-Spike(S1+S2)-E484K mutation(501Y.V2 lineage)	pcDNA3.1(+)
GMV-V-2019nCoV-109	pGM-Spike(S1+S2)RBD triple mutation of 501Y.V2 lineage(K417N, E484K and N501Y)	pcDNA3.1(+)
GMV-V-2019nCoV-111	pGM-Spike (S1+S2) whole mutation variant of SARS-CoV-2(2019nCoV) 501Y.V2 lineage	pcDNA3.1(+)

Codon-optimized viral particle (Adenovirus, Lentivirus, AAV) for SARS-COV-2 (2019nCOV) spike wide type & mutant variants (D614G, N501Y, E484K, B.1.1.7 lineage, 501Y.V2 lineage, and so on)

Cat No.	Gene &Vector description of 2019 nCoV	Vector	Reporter	Order
GMV-V-2019nCoV-051	pGMLV-2019nCoV-spike（S1+S2,C-6His）	Lentiviral vector	Zsgreen
GMV-V-2019nCoV-001	pGMLV-2019nCoV-spike（S1+S2,C-6His）	Lentiviral vector	Zsgreen
GMV-V-2019nCoV-053	Ad-2019nCoV-Spike(S1+S2,C-3FLAG）	Pre-made adenovirus	null
GMV-V-2019nCoV-047	Ad-2019nCoV-Spike(S1+S2,C-3FLAG）	Pre-made adenovirus	EGFP
GMV-V-2019nCoV-002	pGMLV-2019nCoV-S1（C-6His）	Lentiviral vector	Zsgreen
GMV-V-2019nCoV-048	Ad-2019nCoV-Spike(S1 protein,C-3FLAG）	Pre-made adenovirus	EGFP
GMV-V-2019nCoV-003	pGMLV-2019nCoV-Spike RBD（C-6His）	Lentiviral vector	Zsgreen
GMV-V-2019nCoV-007	pGMAAV-2019nCoV-Spike RBD（C-3FLAG）	AAV vector	Zsgreen
GMV-V-2019nCoV-050	AAV-2019nCoV-Spike(S protein RBD,C-3FLAG）	Pre-made AAV	Zsgreen
GMV-V-2019nCoV-049	Ad-2019nCoV-Spike(S protein RBD,C-3FLAG）	Pre-made adenovirus	EGFP
GMV-V-2019nCoV-056	Ad-2019nCoV-Spike D614G (S protein,S1+S2，D614G)	Pre-made adenovirus	null
GMV-V-2019nCoV-103	pGM-2019nCoV-Spike trimer ( P2-mutant,S1/S2 cleavage site（furin cleavage sequence)-mutant,trimerization modified)	Pre-made adenovirus	null
GMV-V-2019nCoV-104	pGM-Spike of SARS-COV-2 B.1.1.7 lineage whole mutation	Pre-made adenovirus	null
GMV-V-2019nCoV-105	Ad-2019nCoV-Spike(S1+S2)-RBD N501Y mutation(B.1.1.7 lineage RBD)	Pre-made adenovirus	null
GMV-V-2019nCoV-106	Ad-2019nCoV-Spike(S1+S2)-S1 HV 69-70 Deletion mutation(ΔH69/ΔV70,B.1.1.7 lineage)	Pre-made adenovirus	null
GMV-V-2019nCoV-108	Ad-2019nCoV-Spike(S1+S2)-E484K mutation(501Y.V2 lineage)	Pre-made adenovirus	null
GMV-V-2019nCoV-110	Ad-Spike(S1+S2)RBD triple mutation of 501Y.V2 lineage(K417N, E484K and N501Y)	Pre-made adenovirus	null
GMV-V-2019nCoV-112	Ad-Spike (S1+S2) whole mutation variant of SARS-CoV-2(2019nCoV) 501Y.V2 lineage	Pre-made adenovirus	null

5. 293T-ACE2 stable cell line & human ACE2 expression vectors: Effector cell of pseudotype virus-Based Neutralization Assay System for efficacy evaluation of COVID-19 vaccines and therapeutic antibodies (Lentiviral pseudovirus)

Human ACE2 overexpression stable HEK293T cell lines. Catalot Number: GM-SC-293T-hACE2-01 Click here for details

Product list: Human ACE2 expression vectors

Cat No.	2019 nCoV related Gene	Gene &Vector description of 2019 nCoV	Vector	Reporter	Tag	codon Optimized	Order
GMV-V-2019nCoV-045	TMPRSS2	pGMLv-hTMPRSS2(C-3FLAG)	Lentiviral vector	Zsgreen	C-3FLAG	No
GMV-V-2019nCoV-041	ACE2	pGMLV-hACE2(C-3FLAG)	Lentiviral vector	Zsgreen	C-3FLAG	No
GMV-V-2019nCoV-042	ACE2	pAD-hACE2(C-3FLAG)	Pre-made Adenovirus	EGFP	C-3FLAG	No
GMV-V-2019nCoV-046	TMPRSS2	pGMLv-mtmprss2(C-3FLAG)	Lentiviral vector	Zsgreen	C-3FLAG	No
GMV-V-2019nCoV-043	ACE2	pAD-mACE2(C-3FLAG)	Pre-made Adenovirus	EGFP	C-3FLAG	No
GMV-V-2019nCoV-044	ACE2	pGMLV-mACE2(C-3FLAG)	Lentiviral vector	Zsgreen	C-3FLAG	No

Validation of hACE2 overexpression stable HEK293T cell lines (Cat. GM-SC-293T‐hACE2-01)

Figure. ACE2 mRNA level Validation in hACE2 overexpression stable HEK293T cell lines: Cat. GM‐SC‐293T‐hACE2‐01 (A) and the cell lines were tested as Mycoplasma free (B).

Products list: Human ACE2 overexpression stable HEK293T cell lines

Cat No.	2019 nCoV related Gene	Gene &Vector description of 2019 nCoV	Vector	Reporter	Tag	codon Optimized	Order
GMV-V-2019nCoV-041	ACE2	pGMLV-hACE2(C-3FLAG)	Lentiviral vector	Zsgreen	C-3FLAG	No
GMV-V-2019nCoV-042	ACE2	pAD-hACE2(C-3FLAG)	Pre-made Adenovirus	EGFP	C-3FLAG	No
GMV-V-2019nCoV-043	ACE2	pAD-mACE2(C-3FLAG)	Pre-made Adenovirus	EGFP	C-3FLAG	No
GMV-V-2019nCoV-044	ACE2	pGMLV-mACE2(C-3FLAG)	Lentiviral vector	Zsgreen	C-3FLAG	No

6. Validated SARS-CoV-2 neutralizing antibodies-benchmark COVID-19 neutralizing antibodies.

Cat No.	Antigen Name of 2019-nCoV(SARS-CoV-2)	Source (Expression Host)	Isotypes	Bioactivity validation	Order
GMP-V-2019nCoV-SnAb001	Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgG1)	Mammalian (human cell)	human IgG1	Validated in COVID-19 Spike protein and Spike-RBD protein binding affnity. COVID-19 related neutralizing potency is validated by 1.2019nCoV pseudotyped virus based neutralization assay in 293T-ACE2 effector cell. 2. competitively blocking the binding of ACE-2 receptor with SARS-CoV-2 Spike protein.
GMP-V-2019nCoV-SnAb002	Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgM)	Mammalian (human cell)	human IgM	Validated in COVID-19 Spike protein and Spike-RBD protein binding affnity. COVID-19 related neutralizing potency is validated by 1.2019nCoV pseudotyped virus based neutralization assay in 293T-ACE2 effector cell. 2. competitively blocking the binding of ACE-2 receptor with SARS-CoV-2 Spike protein.
GMP-V-2019nCoV-SnAb003	Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgA)	Mammalian (human cell)	human IgA	Validated in COVID-19 Spike protein and Spike-RBD protein binding affnity. COVID-19 related neutralizing potency is validated by 1.2019nCoV pseudotyped virus based neutralization assay in 293T-ACE2 effector cell. 2. competitively blocking the binding of ACE-2 receptor with SARS-CoV-2 Spike protein.
GMP-V-2019nCoV-SnAb004	Anti-2019-nCoV Spike (Spike RBD domain) mouse monoclonal neutralizing antibody (IgG1)	Mammalian (human cell)	mouse IgG1	Validated in COVID-19 Spike protein and Spike-RBD protein binding affnity. COVID-19 related neutralizing potency is validated by 1.2019nCoV pseudotyped virus based neutralization assay in 293T-ACE2 effector cell. 2. competitively blocking the binding of ACE-2 receptor with SARS-CoV-2 Spike protein.
GMP-V-2019nCoV-SnAb005	Anti-2019-nCoV Spike (Spike RBD domain) Cynomolgus monoclonal neutralizing antibody (IgG1)	Mammalian (human cell)	Cynomolgus (Non human primate, NHP) IgG1	Validated in COVID-19 Spike protein and Spike-RBD protein binding affnity. COVID-19 related neutralizing potency is validated by 1.2019nCoV pseudotyped virus based neutralization assay in 293T-ACE2 effector cell. 2. competitively blocking the binding of ACE-2 receptor with SARS-CoV-2 Spike protein.

GeneMedi-SARS-CoV-2 WT and Spike Mutation Variants Pseudovirus (PSV) Based Neutralizing 
Assay with GeneMedi's anti-2019-nCoV Spike Neutralizing antibodies (Nabs)

Figure. The Pseudovirus (PSV) Based Neutralizing Assay was performed on 293T-hACE2 cells infected with GeneMedi-SARS-CoV-2 WT and Spike Mutation Variants (D614G, S943P, V367F, G476S, V483A, H49Y, Q239K, A831V, P1263L, D839Y/N/E:D839Y, D839N, D839E) Pseudovirus (PSV) under treatment of GeneMedi's anti-2019-nCoV Spike Neutralizing antibodies (Nabs) . Inhibition rate was determined by comparing the relative RFP+GFP+/GFP+ rate.

GeneMedi's anti-2019-nCoV Spike Neutralizing antibodies (Nabs) and Spike RBD protein binding validation

GMP-V-2019nCoV-SnAb001 Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgG1) 5 GMP-V-2019nCoV-SnAb002 Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgM) 18 GMP-V-2019nCoV-SnAb003 Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgA) 410 GMP-V-2019nCoV-SnAb004 Anti-2019-nCoV Spike (Spike RBD domain) mouse monoclonal neutralizing antibody (IgG1) 6.8 GMP-V-2019nCoV-SnAb005 Anti-2019-nCoV Spike (Spike RBD domain) Cynomolgus monoclonal neutralizing antibody (IgG1) 28

Figure. The binding of GeneMedi's anti-2019-nCoV Spike Neutralizing antibodies (Nabs) to Recombinant 2019-nCoV(SARS-CoV-2) Spike RBD protein (GMP-V-2019nCoV-SRBD001) at 5.0ug/ml (100uL/well) was measured by ELISA. A.GMP-V-2019nCoV-SnAb001:Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgG1) B.GMP-V-2019nCoV-SnAb002:Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgM) C.GMP-V-2019nCoV-SnAb003:Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgA) D.GMP-V-2019nCoV-SnAb004:Anti-2019-nCoV Spike (Spike RBD domain) mouse monoclonal neutralizing antibody (IgG1) E.GMP-V-2019nCoV-SnAb005:Anti-2019-nCoV Spike (Spike RBD domain) Cynomolgus monoclonal neutralizing antibody (IgG1)

GeneMedi's anti-2019-nCoV Spike Neutralizing antibodies (Nabs) competitive binding assay validation

GMP-V-2019nCoV-SnAb001 Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgG1) 26.3 GMP-V-2019nCoV-SnAb002 Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgM) 84.2 GMP-V-2019nCoV-SnAb003 Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgA) 20.5 GMP-V-2019nCoV-SnAb004 Anti-2019-nCoV Spike (Spike RBD domain) mouse monoclonal neutralizing antibody (IgG1) 81.9 GMP-V-2019nCoV-SnAb005 Anti-2019-nCoV Spike (Spike RBD domain) Cynomolgus monoclonal neutralizing antibody (IgG1) 243

Figure. GeneMedi's anti-2019-nCoV Spike Neutralizing antibodies (Nabs) block Recombinant 2019-nCoV(SARS-CoV-2) Spike RBD protein (GMP-V-2019nCoV-SRBD001) and hACE2 (GMP-H-ACE2002) binding. A.GMP-V-2019nCoV-SnAb001:Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgG1) B.GMP-V-2019nCoV-SnAb002:Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgM) C.GMP-V-2019nCoV-SnAb003:Anti-2019-nCoV Spike (Spike RBD domain) human monoclonal neutralizing antibody (IgA) D.GMP-V-2019nCoV-SnAb004:Anti-2019-nCoV Spike (Spike RBD domain) mouse monoclonal neutralizing antibody (IgG1) E.GMP-V-2019nCoV-SnAb005:Anti-2019-nCoV Spike (Spike RBD domain) Cynomolgus monoclonal neutralizing antibody (IgG1)

1) Types of Vaccines (by testing immunized serum from human, mouse, NHP etc.)
2) Neutralizing antibodies
3) Peptides blockers (peptide inhibitors)
4) Compounds targeting Spike induced cell-fusion.

1. 2 Korber, B. et al. Spike mutation pipeline reveals the emergence of a more transmissible form of SARS-CoV-2. bioRxiv Preprint., doi:10.1101/2020.04.29.069054 (2020). 2. Investigation of novel SARS-COV-2 variant. Public health England. 3. European Centre for Disease Prevention and Control. Rapid increase of a SARS-CoV-2 variant with multiple spike protein mutations observed in the United Kingdom – 20 December 2020.ECDC: Stockholm; 2020. 4. Li, G. & De Clercq, E. Therapeutic options for the 2019 novel coronavirus (2019-nCoV). Nature Reviews Drug Discovery, doi:10.1038/d41573-020-00016-0 (2020). 5. Haque, A. & Pant, A. B. Efforts at COVID-19 Vaccine Development: Challenges and Successes. Vaccines 8, doi:10.3390/vaccines8040739 (2020). 6. Dong, Y. et al. A systematic review of SARS-CoV-2 vaccine candidates. Signal Transduction and Targeted Therapy 5, doi:10.1038/s41392-020-00352-y (2020). 7. Andrew Rambaut1, N. L., Oliver Pybus, Wendy Barclay, Jeff Barrett5, Alesandro Carabelli6, Tom Connor, Tom Peacock, David L Robertson8, Erik Volz, . Preliminary genomic characterisation of an emergent SARS-CoV-2 lineage in the UK defined by a novel set of spike mutations. https://virological.org/ (2020). 8. Rapid increase of a SARS-CoV-2 variant with multiple spike protein mutations observed in the United Kingdom. European Centre for Disease Prevention and Control: Publications & data. 9. Zhang, L. et al. SARS-CoV-2 RNA reverse-transcribed and integrated into the human genome. bioRxiv Preprint. , doi:10.1101/2020.12.12.422516 (2020).