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Research ArticleResearch

Quantitative Analysis of Vaccine Antigen Adsorption to Aluminum Adjuvant Using an Automated High-Throughput Method

Patrick L. Ahl, Sheng-Ching Wang, Ramesh Chintala, Christopher Mensch, William J. Smith, Marc Wenger and Jeffrey Blue
PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 149-162; DOI: https://doi.org/10.5731/pdajpst.2017.008250
Patrick L. Ahl
1Vaccine Drug Product Development, Merck Sharp & Dohme Corp., West Point, PA; and
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  • For correspondence: patrick_ahl@merck.com
Sheng-Ching Wang
2Vaccine Process Development, Merck Sharp & Dohme Corp., West Point, PA
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Ramesh Chintala
1Vaccine Drug Product Development, Merck Sharp & Dohme Corp., West Point, PA; and
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Christopher Mensch
1Vaccine Drug Product Development, Merck Sharp & Dohme Corp., West Point, PA; and
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William J. Smith
1Vaccine Drug Product Development, Merck Sharp & Dohme Corp., West Point, PA; and
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Marc Wenger
2Vaccine Process Development, Merck Sharp & Dohme Corp., West Point, PA
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Jeffrey Blue
1Vaccine Drug Product Development, Merck Sharp & Dohme Corp., West Point, PA; and
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Abstract

Aluminum-containing adjuvants have been widely used in vaccine formulations to safely and effectively potentiate the immune response. The examination of the extent of antigen adsorption to aluminum adjuvant is always evaluated during the development of aluminum adjuvant containing vaccines. A rapid, automated, high-throughput assay was developed to measure antigen adsorption in a 96-well plate format using a TECAN Freedom EVO® (TECAN). The antigen adsorption levels at a constant adjuvant concentration for each sample were accurately measured at 12 antigen/adjuvant (w/w) formulation ratios. These measurements were done at aluminum adjuvant concentrations similar to normal vaccine formulations, unlike previous non-automated and automated adjuvant adsorption studies. Two high-sensitivity analytical methods were used to detect the non-absorbed antigens. The antigen-to-adjuvant adsorption curves were fit to a simple Langmuir adsorption model for quantitatively analyzing the antigen to the adjuvant adsorption level and strength. The interaction of two model antigens, bovine serum albumin and lysozyme, with three types of aluminum adjuvant, were quantitatively analyzed in this report. Automated, high-throughput methodologies combined with sensitive analytical methods are useful for accelerating practical vaccine formulation development.

LAY ABSTRACT: Vaccines are probably the most effective public health method to prevent epidemics of many infectious diseases. Many of the most effective vaccines contain aluminum adjuvant. This report describes novel technology that can be used to better optimize the efficacy and stability of aluminum adjuvant–containing vaccines.

  • Vaccine formulation
  • Aluminum adjuvant
  • antigen adsorption
  • Automation
  • Abbreviations:

    AAHS
    amorphous aluminum hydroxyphosphate sulfate adjuvant
    Al
    elemental aluminum
    AlOH
    aluminum hydroxide adjuvant
    AP
    aluminum phosphate adjuvant
    BPP
    Biologics Pilot Plant
    BSA
    bovine serum albumin
    BSA-Alexa488
    bovine serum albumin labeled with Alexa488 fluorophore
    Dtap-IVP/Hib
    diphtheria, tetanus, cellular pertussis, inactivated polio virus, haemophilus influenza b vaccine
    CV%
    coefficient of variation %
    FDA
    Food and Drug Administration
    Hep A
    hepatitis A virus
    Hep B
    hepatitis B virus
    HPV
    human papilloma virus
    HT
    high-throughput
    LINEST
    Microsoft Excel® function that calculates the statistics of values fitting a line using the least squares method
    Lyso
    lysozyme
    Lyso-FITC
    lysozyme labeled with FITC fluorophore
    MMD
    Merck Manufacturing Division (West Point, PA)
    MW
    molecular weight
    P
    elemental phosphorous
    PCV13
    pneumo conjugate vaccine 13 serotype antigens
    pI
    protein isoelectric point
    PZC
    point of zero charge
    TECAN
    TECAN Freedom EVO® laboratory automation instrument
    VLP
    virus-like particle
    • © PDA, Inc. 2018
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    PDA Journal of Pharmaceutical Science and Technology: 72 (2)
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    Vol. 72, Issue 2
    March/April 2018
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    Quantitative Analysis of Vaccine Antigen Adsorption to Aluminum Adjuvant Using an Automated High-Throughput Method
    Patrick L. Ahl, Sheng-Ching Wang, Ramesh Chintala, Christopher Mensch, William J. Smith, Marc Wenger, Jeffrey Blue
    PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 149-162; DOI: 10.5731/pdajpst.2017.008250

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    Quantitative Analysis of Vaccine Antigen Adsorption to Aluminum Adjuvant Using an Automated High-Throughput Method
    Patrick L. Ahl, Sheng-Ching Wang, Ramesh Chintala, Christopher Mensch, William J. Smith, Marc Wenger, Jeffrey Blue
    PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 149-162; DOI: 10.5731/pdajpst.2017.008250
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    Keywords

    • Vaccine Formulation
    • Aluminum Adjuvant
    • Antigen Adsorption
    • Automation

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