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Related Experiment Video

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The CombE-IDMS Alternate Potency Method for H5N1 and H5N8 Cell-Based Vaccines.

Matthew P Donohue1, Zhijun Cao1, Thomas Bowen1

  • 1Biopharmaceutical Product Development, CSL Seqirus, Holly Springs, NC 27540, USA.

Vaccines
|December 23, 2023
PubMed
Summary

A new mass spectrometry assay, CombE-IDMS, offers a faster alternative for testing influenza vaccine potency. It accurately measures vaccine strength without traditional reagents, proving effective for seasonal and pandemic strains.

Keywords:
alternate potencyavian influenzaforced degradationhemagglutinin (HA)isotope dilution mass spectrometry (IDMS)

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Area of Science:

  • Vaccinology
  • Analytical Chemistry
  • Biotechnology

Background:

  • The current standard for influenza vaccine potency testing is single radial immunodiffusion (SRID).
  • SRID relies on calibrated reagents (antisera and antigen standards) that can cause distribution delays, particularly during pandemics.
  • A faster, deployable alternative is needed to ensure timely vaccine availability.

Purpose of the Study:

  • To evaluate the CombE-IDMS assay as a potential alternative to SRID for influenza vaccine potency.
  • To demonstrate the applicability of CombE-IDMS to pre-pandemic H5N1 and H5N8 influenza vaccine materials.
  • To assess the performance of CombE-IDMS under various stress conditions.

Main Methods:

  • CombE-IDMS, a mass spectrometry-based assay, was used to measure vaccine potency.
  • The assay was applied to seasonal quadrivalent cell-based vaccine materials (aQIVc).
  • Forced degradation studies (thermal, pH, oxidative, freeze/thaw) were performed on H5N1 and H5N8 monovalent vaccine materials (unadjuvanted and adjuvanted).

Main Results:

  • CombE-IDMS results correlated well with the gold standard SRID method for aQIVc materials.
  • The assay successfully measured potency for both unadjuvanted and adjuvanted H5N1 and H5N8 vaccine materials.
  • CombE-IDMS demonstrated consistent performance across various stress conditions, mirroring SRID outcomes.

Conclusions:

  • CombE-IDMS is a viable, rapid alternative for assessing influenza vaccine potency.
  • The assay's independence from traditional reagents makes it suitable for pandemic preparedness.
  • CombE-IDMS shows promise for routine use in seasonal and pandemic influenza vaccine manufacturing.