vaxarray流感效力測試分析系統(tǒng)

indevr的vaxarray平臺能夠在新型流感疫苗生產平臺中優(yōu)化疫苗的生物過程,該公司計劃在這一成功的基礎上積極拓展新的應用途徑,盡可能降低生產公共衛(wèi)生疫苗和生物治療藥物的復雜性、執(zhí)行時間和成本。

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.

The VaxArray® Influenza Seasonal Neuraminidase (NA) Potency Test Kit contains 32 microarrays and most of the reagents needed to quantify N1, N2, and B NA from both B/Yamagata-like and B/Victoria-like viruses. The test is a multiplexed immunoassay in which a panel of monoclonal antibodies is used to capture subtype-specific antigen. Readout is based on fluorescence from an antigen-specific “label” antibody conjugated with a proprietary fluorophore. The arrangement of monoclonal capture antibodies within each microarray (i.e., within each well) is shown in the figure below.

Assay features include:

• Subtype Specific and Multiplexed. Quantify any or all components of a quadrivalent formulation (note that B NA has not diverged for the two HA lineages). The microarray utilizes multiple antibodies for each subtype with 9 replicates per antibody in a single test, providing high confidence in results for protein quantification.
• Excellent Correlation with Enzymatic Activity. Each antibody within the microarray has been shown to exhibit excellent correlation with enzymatic activity, including after forced thermal degradation.
• Most Robust than Activity Assays.  No need for finicky enzymes, the assay is conducted at room temperature and the quantification range is generally 10-100x larger than the typical range for enzymatic activity assays.
• Stability Indicating. The test has been demonstrated to quantify biologically relevant forms of NA.
• Compatibility with Adjuvants. NA quantification is robust even in the presence of common adjuvants at dose-sparing antigen concentrations.
• Off-the-Shelf Kit. Eliminates need for in-house preparation of plates or gels; streamlines testing.
• Fast & High Throughput.  With a turn-around time of <2 hours, a single analyst can easily quantify 48 samples in a half day.
• Automated Image and Data Processing. Software developed with FDA 21 CFR Part 11 + EU Annex 11 compatible features reduces time spent processing data, enables straightforward data integrity compliance, and maintains digital records with audit log traceability.

Please refer to the Literature tab for links to scientific publications as well as application and technical notes.