The VaxArray® Platform
Simplify & Accelerate Potency Testing
The VaxArray Influenza Potency test is 24x faster and 100x more sensitive than SRID. In contrast to SRID, these test kits are available for year-round use – even prior to reference reagent availability. The easy-to-use test kits are based on multiplexed sandwich immunoassays that accurately quantify the potency of influenza vaccines within 2 hours. The test kits rely on broadly reactive yet subtype specific monoclonal antibodies in a microarray format. This innovative multiplexed system enables simultaneous analysis of multiple antigens within vaccines, significantly reducing cost and testing time. VaxArray reagent kits are manufactured under cGMP conditions within ISO 13485:2016 certified facilities. The operational software is 21 CFR Part 11 +Annex compatible.
VaxArray can be used to track hemagglutinin at each step in the manufacturing process, from seed strain optimization to monovalent bulk stability assessment during storage. Implementation of a single, consistent potency assay throughout the production process allows for accurate evaluation of protein recovery and process improvements.
For final formulation and lot release testing, VaxArray exhibits equivalence to SRID when calibrated with appropriate reference reagents (see recent publications). Since VaxArray does not rely on reference antisera, it can be applied early in the manufacturing process to reduce risk by enabling accurate potency evaluation prior to reference reagent release.
- Standardize and track potency throughout production
- Improve workflow, streamline QC testing, reduce cost by reducing testing time by 24x
- Instantly create a digital record to enable data integrity compliance
- Reduce risk by reliably tracking monobulk stability during storage prior to final formulation
- Easily bridge to SRID for equivalent lot release testing
- Software is 21 CFR Part 11-compatible, with features such as user based access, audit trails, and electronic signatures
In general, the VaxArray Influenza potency test is 100x more sensitive than SRID. As result, in conjunction with our proprietary protein blocking buffer (included), the test can be used to quantify low concentrations of HA in complex media, such as allantoic fluid or in an adjuvanted low-dose vaccine. Because of these unique features, with VaxArray you can:
- Streamline seed strain optimization
- Quantify antigen recovery in-process
- Quickly and efficiently explore process improvements
- Track monobulk intermediate stability prior to release of reference reagents
- Track stability of all antigen components in multivalent formulation pre & post lot release
The VaxArray potency test relies on a sample pre-treatment step with a detergent (typically zwittergent 3-14) to ensure consistency with the forms of HA detected. This step allows the test to be applied to whole viruses, split viruses, subunit vaccines, and recombinant protein vaccines.
VaxArray has proven effective for the following flu vaccines and emerging vaccines:
- Virus-like particles
- “Universal” (chimeric)
- Adjuvanted, low-dose
Compatibility with the latest strains of flu viruses…The monoclonal antibodies (mAbs) used in the VaxArray potency test kits are selected to exhibit broad coverage and to reliably quantify subtypes from the most current strains of influenza viruses. We work closely with scientists at the FDA and CDC to test new viruses as they emerge to ensure that the mAbs within each test kit are responsive to new strains. From time to time it will be necessary to update the mAbs and InDevR has developed a standard V&V process to do so. We will work closely with our customers to ensure that test kit versions are available as needed for internal V&V activities.
- VaxArray assessment of influenza split vaccine potency and stability
- Titer on Chip: New Analytical Tool for Influenza Vaccine Potency Determination
- VaxArray Seasonal 2017 World Vaccines Poster
- VaxArray Seasonal 2017 ESACT Poster
- VaxArray Seasonal 2016 Options Poster
- VaxArray Seasonal Influenza App Note #1 Stability Indicating
- VaxArray Seasonal Influenza App Note #2 Monovalent, Multivalent Vaccines
- VaxArray Seasonal Influenza App Note #3 Virion Splitting
- VaxArray Seasonal Influenza App Note #4 Crude Samples
- VaxArray Seasonal Influenza Tech Note Specificity
- VaxArray Seasonal Influenza Tech Note Accuracy and Precision
- VaxArray Seasonal Influenza Tech Note SRID Correlation
- VaxArray Seasonal Influenza Tech Note Calibration Standards
- VaxArray Seasonal Influenza Tech Note Concentration
- VaxArray Data Extraction and Analysis Tech Note
- VaxArray Imaging System Declaration of Conformity
- VaxArray Influenza Comparison Chart
- VaxArray HA Comparison to SRID
- VaxArray Seasonal Influenza Product Sheet
- VaxArray Pandemic Influenza Product Sheet
Q1) Are the antibodies of the VaxArray Influenza Seasonal Hemagglutinin Potency Test Kit sufficiently broadly reactive to detect the targeted HA in the event of antigenic drift?
A1) Yes. The VaxArray Influenza Seasonal Hemagglutinin Potency Test Kit’s panel of antibodies have demonstrated broad coverage of historical vaccines dating back over 15 years. However, because future antigenic drift is difficult to predict, InDevR has developed a process for evaluating assay performance against novel influenza strains.
Q2) Can VaxArray be used with crude and in-process samples?
A2: Yes. Low limits of detection and high sensitivity allow quantification even in difficult matrices.
Q3) Can VaxArray be used to quantify HA from live, active virus?
A3) Yes. Active or inactive viral material is able to be quantified using VaxArray.
Q4) Is VaxArray stability indicating?
A4) Yes. By using conformational epitopes for antigens of interest, VaxArray is able to quantify the biologically relevant forms of antigenic proteins.
Q5)What types of vaccine does VaxArray work with?
A5) Many types of vaccine can be characterized using VaxArray. Split, live-attenuated, recombinant, whole virion and others can be easily quantified for antigenic protein content.
Q6) Can I use an internal standard for VaxArray?
A6) Yes. Internal standards work very well in our assay as inactivation conditions are usually well matched between internal standards and sample.
Q7) How do I gather and analyze the data from the slide after processing?
A7) InDevR has developed a VaxArray specific software package that is installed on the VaxArray Imaging System. This intuitive software package will walk you through the set-up, imaging, and analysis of data. Results are presented in easy to understand reports.
Q8) Is the VaxArray Software 21 CFR Part 11 compatible?
A8) Yes, digital signatures, user permissions and audit reports allow compatibility with 21 CFR Part 11 requirements.
Q9) How can I know that the VaxArray assay is appropriate for my samples?
A9) The VaxArray science team is here for you! Our team of expert scientists will discuss your sample and analysis needs with you to determine the best course of action. Custom development is available for samples that do not fit our current VaxArray Assay Kit offerings.
Q10) Is VaxArray only for influenza vaccines?
A10) InDevR is working to expand the applications of VaxArray technology to other vaccines. Talk to our Sales Representatives about custom development specific for your needs.