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 
  • >65,000 samples analyzed in 2019
  • >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
  • Selected by 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 Tetanus
H. influenzae type b Vaccinia
Hepatitis B Varicella zoster virus
Human papilloma virus West Nile virus
Influenza (seasonal and pandemic strains) Yellow Fever virus
Japanese encephalitis virus 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
  • Type-specific microneutralization
  • Vector-specific quantitative PCR (qPCR)
  • 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)
Dengue virus
  • Serotype-specific neutralization (multiple platforms)
  • Serotype-specific quantitative RT-PCR

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 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
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.

Our vaccine laboratory services are highlighted in a recent New England Journal of Medicine Article, where Q2 Solutions played a major role in establishing efficacy for an Influenza vaccine licensure.
Keeping Up with the Flu: Advances in seasonal influenza vaccine development

Comparison of Zika Virus Neutralization Platforms: PRNT and RVP

World Vaccine Congress 2019 Presentation

A Proactive Approach to Ebola Vaccine Development

Best practices for rapid test development and regulatory approvals

New Approaches for Malaria Vaccine Development

How advances in genetic engineering have brought new hope to conquering malaria

Read More