VaxArray assessment of influenza split vaccine potency and stability

Area of Science:

• Vaccinology
• Immunology
• Analytical Chemistry

Background:

• Current influenza vaccine potency and stability testing relies on the single radial immunodiffusion (SRD) assay, which has limitations.
• Accurate and rapid characterization tools are essential for vaccine manufacturers to ensure product quality.

Purpose of the Study:

• To evaluate the VaxArray Influenza (VXI) assay for quantifying potency and stability of finished influenza vaccines.
• To assess VXI's capability in measuring hemagglutinin protein (HA) in crude, in-process vaccine samples.

Main Methods:

• VaxArray Influenza (VXI) assay was used to test monobulk intermediates and mono- and multivalent vaccines.
• Quantification of HA in crude samples was performed by spiking known HA concentrations.
• Stability was assessed by comparing VXI and SRD potency measurements after heat stress.

Main Results:

• VXI demonstrated high accuracy (±10%) and precision (CV 10±4%) for potency measurements, comparable to SRD.
• VXI exhibited a 12x greater linear dynamic range and a ≥600x lower limit of detection compared to SRD.
• VXI successfully quantified HA in crude samples (0.02% total protein) and showed stability-indicating capability.

Conclusions:

• The VaxArray Influenza (VXI) assay is a rapid, multiplexed immunoassay suitable for accurate flu vaccine potency determination.
• VXI offers significant advantages over SRD in terms of sensitivity, dynamic range, and applicability to crude samples.
• VXI can be reliably used for assessing both finished vaccine products and upstream process intermediates.