Immunoassay capabilities
Our assay development team members are immunology experts. We take a consultative approach to assay development with our customers, to maximize the potential of the data produced. To support this process, we have standardized in-house protocols to draw from, meaning new assays can be taken from concept to validation rapidly. Our team focuses on cellular and humoral immunoassays, and has capabilities and expertise on the associated laboratory techniques and platforms.
Our assay development team members are immunology experts. We take a consultative approach to assay development with our customers, to maximize the potential of the data produced. To support this process, we have standardized in-house protocols to draw from, meaning new assays can be taken from concept to validation rapidly. Our team focuses on cellular and humoral immunoassays, and has capabilities and expertise on the associated laboratory techniques and platforms.
Today, we are equipped to evaluate:
- T cells: Memory/differentiation status, T reg differentiation cytokine profile effector function, cytotoxicity, activation exhaustion, transcription factor profile, survival and signaling
- B cells: Memory/differentiation status, plasma cell development isotype class switching, cytokine production, activation transcription factor profile, survival signaling
- Dendritic cells: Subset analysis, T cell activation
- Antibodies: Target protein binding, isotype classification
Assay types we currently offer:
- Enzyme-linked immunospot assays (ELISPOT)
- Multi-parametric flow cytometry (up to 16 parameters)
- 2- color ELISPOT
- Enzyme-linked immunosorbent assay (ELISA)
- Multiplex analysis (up to 50 analytes simultaneously)
Expertise in ELISPOT
Using ELISPOT technology to evaluate immune cell function provides unique insights and data when evaluating a vaccine or immunotherapy’s efficacy during clinical trials. However, there are also unique challenges with this technology that are especially noticeable as clinical trials begin to increase participant enrolment across many global trial sites. The Certimmune team has access to proven ELISPOT techniques, through their experience with the propriety T-SPOT platform, that allows for quality, reproducible ELISPOT data to be produced, even at a high-volume, globally.
Using ELISPOT technology to evaluate immune cell function provides unique insights and data when evaluating a vaccine or immunotherapy’s efficacy during clinical trials. However, there are also unique challenges with this technology that are especially noticeable as clinical trials begin to increase participant enrolment across many global trial sites. The Certimmune team has access to proven ELISPOT techniques, through their experience with the propriety T-SPOT platform, that allows for quality, reproducible ELISPOT data to be produced, even at a high-volume, globally.
Multi-parametric flow cytometry
The Certimmune team has the capability and facilities to perform multi-parametric flow cytometry at high volumes. Our experts can work with your clinical teams to create the right cytometry panels and readouts for your clinical trial. Additional, Certimmune has standardized validation and protocol implementation, and a team with experience running high volume testing, ensuring data quality is not compromised as the trial ramps up. We use flow cytometry equipment that allows for up to 16 parameters to be run with each sample, meaning maximum data readouts so you can learn as much as possible about how the adaptive immune system is responding to your vaccine or immunotherapy.
The Certimmune team has the capability and facilities to perform multi-parametric flow cytometry at high volumes. Our experts can work with your clinical teams to create the right cytometry panels and readouts for your clinical trial. Additional, Certimmune has standardized validation and protocol implementation, and a team with experience running high volume testing, ensuring data quality is not compromised as the trial ramps up. We use flow cytometry equipment that allows for up to 16 parameters to be run with each sample, meaning maximum data readouts so you can learn as much as possible about how the adaptive immune system is responding to your vaccine or immunotherapy.
- Clinical expertise: experts who can work with your clinical teams to create the right flow cytometry panels and readouts for your clinical trial
- High-volume capabilities: standardized validation and protocol implementation by a team with experience running high-volume testing
- Well-equipped laboratory: ability to readout up to 16 parameters
Simplified clinical trial logistics
Assessing the function of T cells or other immune cells requires healthy, living cells after sample transport, regardless of whether the samples will be tested when fresh, or cryopreserved for further evaluation. The Certimmune team can evaluate non-frozen blood samples up to 32 hours after collection, utilizing the proprietary T-Cell Xtend reagent.
By extending blood stability to 32 hours, working with the Certimmune team can help simplify trial logistics, increase enrolment across trial sites, reduce logistics costs, all without compromising data quality.1
Assessing the function of T cells or other immune cells requires healthy, living cells after sample transport, regardless of whether the samples will be tested when fresh, or cryopreserved for further evaluation. The Certimmune team can evaluate non-frozen blood samples up to 32 hours after collection, utilizing the proprietary T-Cell Xtend reagent.
By extending blood stability to 32 hours, working with the Certimmune team can help simplify trial logistics, increase enrolment across trial sites, reduce logistics costs, all without compromising data quality.1
- Samples can be collected at a further distance from the laboratory --> More recruitment sites can participate in CMI testing
- Enrollment sites can collect samples later in the day à Easier patient recruitment
- Able to use of an overnight, room temperature courier service à Lower logistics costs
- Ability to test T cell samples up to 32 hours à No concession on data quality in order to test samples after 8 hours
Capacity for high-volume testing
Managing technical assays at high volume without compromising data quality is a big challenge as clinical trials begin to scale up to phase 2 and phase 3. However, the operations team at Certimmune have experience running cellular immunoassays at high volumes, making us an ideal solution for large clinical cohorts. As of 2022, we have processed over 135,000 clinical trial samples. This work includes running complex ELISPOT and flow cytometry assays, as well as PBMC isolation and cryopreservation.
Managing technical assays at high volume without compromising data quality is a big challenge as clinical trials begin to scale up to phase 2 and phase 3. However, the operations team at Certimmune have experience running cellular immunoassays at high volumes, making us an ideal solution for large clinical cohorts. As of 2022, we have processed over 135,000 clinical trial samples. This work includes running complex ELISPOT and flow cytometry assays, as well as PBMC isolation and cryopreservation.
Global lab network
We have an established global network of trusted laboratories who have worked with us to implement our IVD test kits into their own labs. We are now working with many of these same labs to provide testing services for our Certimmune customers. Our lab operations team can identify, evaluate, train, onboard, and monitor labs in any geography necessary to support your clinical trial sites.
We have an established global network of trusted laboratories who have worked with us to implement our IVD test kits into their own labs. We are now working with many of these same labs to provide testing services for our Certimmune customers. Our lab operations team can identify, evaluate, train, onboard, and monitor labs in any geography necessary to support your clinical trial sites.
Quality assurance
Our laboratories, and any services we provide, are guided by our experienced Quality Assurance and Clinical Affairs teams. Our laboratories are held to GCP as standard, using FDA approved QMS systems. In turn, this ensures the highest quality clinical trial data is produced for your regulatory submissions.
Our laboratories, and any services we provide, are guided by our experienced Quality Assurance and Clinical Affairs teams. Our laboratories are held to GCP as standard, using FDA approved QMS systems. In turn, this ensures the highest quality clinical trial data is produced for your regulatory submissions.