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 13485:2003 certified facilities. The operational software is 21CFR Part 11 +Annex compatible.
VaxArray® Imaging System and Software
The VaxArray Imaging System (VX-6000) is a compact instrument that enables high-resolution fluorescence imaging of both microarray slides and 96 well plates. The system is sold with intuitive 21 CFR Part 11 +Annex compatible software for use with the VaxArray Influenza potency test kits.
VaxArray Potency Test Kits
Each kit comes with two, 16 microarray slides and enables quantitative analysis of up to 24 samples or qualitative analysis of up to 32 samples. With two exceptions, the kit contains all of the ancillary reagents needed to conduct the assay (e.g., wash buffers, protein blocking buffer, etc.).
The VaxArray Potentency Test Kits for hemagglutinin currently offered by InDevR are:
Reference Antigens. The user must identify and obtain an appropriate reference antigen, which can be an ERL-approved standard or an internal standard characterized by a purity adjusted total protein method.
Choose the Best Fluor-Tagged Antibody Label. The user must select and order the appropriate fluor-tagged label antibody from the range offered by InDevR. In general, for egg-propagated vaccines we recommend the nearly universal polyclonal vaccine (VXI-7601) for ease of use and broad applicability. For cell-propagated vaccines, recombinant proteins, or virus-like particles, it is recommend that you review the Label Selection Guide or, better yet, speak with our scientists about which label antibodies to try. It is sometimes necessary to evaluate a panel of label antibodies to optimize sensitivity.
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.
The VaxArray system provides a user-friendly interface for automated data analysis. Automated analysis reduces time spent collecting data and eliminates subjectivity through a standardized data processing algorithm. The software is compatible with 21 CFR Part 11 + annex for easy integration into your process for ensuring data integrity.
Computer and Software:
Results Storage Format: CSV, JPG, PDF
Operating System: Windows 10 Professional
- 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 Influenza Tech Note Calculations
- 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 (Kuck, 2014). However, because future antigenic drift is difficult to predict, InDevR has developed a process for evaluating assay performance against novel influenza strains. Through close collaboration government agencies we will screen against emerging strains and if needed, efficiently evaluate new antibodies and update the assay as needed.
Q2) How does InDevR ensure that the reagent kit is suitable for the seasonal strains chosen by the WHO in February of each year?
A2: InDevR has developed a process for evaluating the assay and reagents performance against any new strains suggested by the WHO. In the event that a new strain performs poorly with the current set of reagents, InDevR rapidly screens alternative antibody and reagent options for the best replacement. The reagent kit will be updated and qualified accordingly.
Q3) What are the characteristics of each antibody in terms of origin, epitope detected, etc.?
A3) Below is a detailed array table that summarizes relevant information for each antibody. These tables describe the conformation type detected (linear vs. conformational), the general binding location (if known), and the detection target(s) of the antibody. We hold all other information as proprietary.
Q4) Is the label antibody a monoclonal or polyclonal antibody?
A4) InDevR offers a number of label antibody options. The most popular is a “universal” polyclonal label but multiple monoclonal labels are also available for greater sensitivity to protein structure. Please refer to the Label Selection Guide for more information on which label antibody is best for your needs.
Q5) How do I determine which label antibody I should use?
A5) Please refer to the Label Selection Guide for Seasonal or Pandemic for more information on which label antibody is best for your sample and needs. The team of InDevR scientists will also be happy to help you to select the appropriate antibody for your specific sample and analysis needs. The polyclonal label is the most flexible and is appropriate for most samples, while the monoclonal labels tend to be more sensitive to protein structure and provide better coverage for some sample types, such as recombinant proteins.
Q6) Why is the VaxArray assay so sensitive considering the usually high concentration of HA in vaccine production?
A6) This is just the nature of the assay. High sensitivity provides a significant benefit to the assay as it allows for large dilution into our high performance Protein Blocking Buffer. Large dilution factors help reduce the amount of sample required, while also diluting out interfering agents such as crude matrix proteins, sucrose, and adjuvants. Unlike SRID, which does not function well with these interfering agents, the VaxArray assay is capable of quantifying HA from all steps of the production process.
Q7) Why is Zwittergent used in the first stage of sample processing? For most ELISA methods it is not required.
A7) Zwittergent is the detergent most commonly used for SRID analysis. We have adapted this to our assay to ensure that the structure of HA (trimer, oligomer, etc.) analyzed by SRID is also being analyzed by the VaxArray assay.
Q8) Can the VaxArray assay be used to quantify HA from live, active virus?
A8) Yes. The initial step of the assay is to lyse the sample with Zwittergent which is generally considered to split 100% of whole virions. At this point, the sample can usually be analyzed on the benchtop. The high sensitivity of the assay also allows for the dilution of interfering agents such as allantoic proteins, sucrose, and cell-culture media.
Q9) Which reference antigen should I choose for my analysis?
A9) As with SRID analysis, the sample and standard should be matched strains. We have shown that not all reference antigens are the same and have some preliminary evidence that BPL-inactivated reference antigens are more appropriate than formaldehyde-inactivated reference antigens. As a rule, each laboratory should investigate this and determine which standard is most appropriate for their needs.
Q10) Can I use an internal standard for VaxArray?
A10) Yes! Internal standards work very well in our assay as inactivation conditions are usually well matched between internal standards and sample.
Q11) How do I gather and analyze the data from the slide after processing?
A11) InDevR has developed a VaxArray specific software package that is loaded onto 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.
Q12) How can I know that the VaxArray assay is appropriate for my samples?
A12) 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.