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Assessing Antigen-Adjuvant Complex Stability Against Physical Stresses By wNMR

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Abstract

This study applies an emerging analytical technology, wNMR (water proton nuclear magnetic resonance), to assess the stability of aluminum adjuvants and antigen-adjuvant complexes against physical stresses, including gravitation, flow and freeze/thaw. Results from wNMR are verified by conventional analytical technologies, including static light scattering and microfluidic imaging. The results show that wNMR can quickly and noninvasively determine whether an aluminum adjuvant or antigen-adjuvant complex sample has been altered by physical stresses.

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Funding

This work was supported by NIIMBL (the National Institute for Innovation in Manufacturing Biopharmaceuticals) though grant PC2.2–077.

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Author notes

  1. Akhilesh Bhambhani

    Present address: Biologics and mRNA Drug Product Development, Tech Dev/Tech Ops, Ultragenyx Pharmaceutical, Brisbane, California, 94005, USA

Authors and Affiliations

  1. University of Maryland School of Pharmacy and Institute for Bioscience and Biotechnology, Rockville, Maryland, 20850, USA

    Marc B. Taraban, Katharine T. Briggs & Yihua Bruce Yu

  2. Pfizer, Inc., Chesterfield, Missouri, 63017, USA

    Michael T. Jones & Lindsey Rosner

  3. Pharmaceutical Sciences and Clinical Supply, Merck & Co., Inc., Rahway, New Jersey, 07065, USA

    Akhilesh Bhambhani & Donna M. Williams

  4. Analytical Research and Development, Merck & Co., Inc., Rahway, New Jersey, 07065, USA

    Christopher Farrell, Mikhail Reibarkh & Yongchao Su

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  1. Marc B. Taraban
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Correspondence to Yihua Bruce Yu, Michael T. Jones, Akhilesh Bhambhani or Yongchao Su.

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Pfizer and Merck authors declared no conflict of interests. UMB authors, M.B.T., K.T.B. and Y.B.Y., are co-inventors of issued and pending patents on wNMR owned by UMB.

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Taraban, M.B., Briggs, K.T., Yu, Y.B. et al. Assessing Antigen-Adjuvant Complex Stability Against Physical Stresses By wNMR. Pharm Res 40, 1435–1446 (2023). https://doi.org/10.1007/s11095-022-03437-1

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