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Vaccine Laboratory Services

Q2 Solutions vaccine laboratory services are supported by global, comprehensive central laboratory services to meet your development needs across the entire vaccine development life cycle

Q2 Solutions Vaccines at a glance:

  • ~12,000 Sq. ft vaccine laboratory located in San Juan Capistrano, CA
  • ISO 9001 (2015) certified 
  • Selected as one of the Coalition for Epidemic Preparedness Innovation (CEPI) core immunogenicity testing laboratories
  • >900,000 samples tested for >175 Phase I to IV studies over the last 10 years
  • Played a critical role in the development of >25 vaccines and therapeutic agents for >30 clients 
  • Sole commercial central laboratory approved by FDA for Ebola ELISA testing
  • Collaborates with WHO and other global organizations to provide insights


Our clinical trial vaccine laboratory services include:

  • Lab services to support vaccine immunogenicity and efficacy studies
  • Viral and bacterial neutralization assays across multiple platforms: PRNT, RVP, microneutralization
  • Custom PCR development to support vector-specific detection
  • Immunoassay development in ELISA and Luminex platforms
  • Full range of lab services to support influenza vaccine trials  


With over 35 years of experience in clinical vaccine development, our experts help you select the custom assay level most suited to the clinical phase of your compound: Fit-for-purpose, Qualified, or Validated. We offer our experience in the following:

Vaccine/pathogen targets
Adenovirus Mumps
IChikungunya Norovirus
Cholera Respiratory syncytial virus
Dengue Rubella
Ebola virus SARS-CoV-2
H. influenzae type b Tetanus
Hepatitis B Vaccinia
Human papilloma virus Varicella zoster virus
Influenza (seasonal and pandemic strains) West Nile virus
Japanese encephalitis virus Yellow Fever virus
Measles  Zika virus

 

Platforms and assay methods
ELISA RT-PCR, qualitative and quantitative
Enzyme-linked lectin assay (ELLA) Plaque reduction neutralization (PRNT)
Hemagglutination inhibition assay (HAI) Vibriocidal assay
Luminex platform Viral culture – conventional
Microneutralization Viral culture – quantitative (TCID50)
NexGen Sequencing Viral neutralization with immunostaining
PCR, qualitative and quantitative Viral neutralization with replicating viral particles (RVP)

 

Examples of assay development by various pathogens
Adenovirus
  • ELISA
  • Type-specific microneutralization
  • Vector-specific quantitative PCR (qPCR)
Dengue virus
  • IgG/IgM/NS1 ELISA
  • Serotype-specific neutralization (multiple platforms)
  • Serotype-specific quantitative RT-PCR
Influenza
  • Hemagglutination agglutination (HAI)
  • Microneutralization
  • Neuraminidase inhibitory antibody (ELLA)
  • Influenza A/B detection and subtyping (RT-PCR)
  • Influenza strain identification by NexGen Sequencing
  • Influenza culture and viral expansion
  • Quantitative viral culture (TCID50)
SARS-CoV-2
  • Multiplex Antibody Assay
  • Viral Neutralization Assay


Test Menu

Infectious Agents/ Test Method
Adenovirus Serotypes 4 and 7 Microneutralization (MN)
Chikungunya Virus Microneutralization*
Dengue IgG ELISA
Dengue IgM ELISA
Dengue IgG/IgM ELISA
Dengue IgG/IgM/NS1 ELISA
Dengue NS1 ELISA
Dengue Virus Focus Reduction Neutralization (FRNT)
Dengue Virus Qualitative RT-PCR
Ebola Zaire ELISA (FANG ELISA)
Ebola Zaire Plaque Reduction Neutralization Test (PRNT) (Not Wild type)*
Haemophilus influenzae Tybe b (Hib) IgG ELISA
Quantitative HBV Surface Antibody IgG (Vitros)
Influenza A H1/H3 Subtyping by RT-PCR
Influenza A/B Conventional Culture – MDCK
Influenza A/B Conventional Culture – RhMK
Influenza A/B RNA by Qualitative RT-PCR
Influenza A/B RNA by Quantitative RT-PCR
Influenza A/B/ RSV by Qualitative RT-PCR
Influenza A/B Strain Sequencing (NGS Sequencing)*
Influenza Hemagglutination Inhibition (HAI) (Seasonal and pandemic strains)
Influenza Neuraminidase Inhibitory Antibody Detection by ELLA – N1 antigen*
Influenza Nueraminidase Inhibitory Antibody Detection by ELLA – N2 antigen*
Influenza Quantitative Culture (TCID50)*
Influenza Viral Expansion – MDCK
Influenza Viral Expansion – RhMK
Influenza Virus Microneutralization (MN)*
MMRV Quantitative IgG by Luminex®
Norovirus Histoblood Group Antigen Blocking ELISA*
Ross River Virus (RRV) IgG ELISA
SARS-CoV-2 Multiplex Antibody Assay
SARS-CoV-2 Viral Neutralization Assay
Vaccinia Plaque Reduction Neutralization Test (PRNT)*
West Nile Virus Microneutralization (MN)
Yellow Fever Plaque Reduction Neutralization Test (PRNT)*
Zika Virus Microneutralization*

*Custom assay development and validation available for these assays to meet your unique vaccine needs.


>35 Years Experience in infectious disease and immunology assay development and clinical diagnostic testing

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