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
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
|
Influenza
|
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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