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Research ArticleTechnology/Application

Control Strategy Approach for a Well-Characterized Vaccine Drug Product

Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez and Katherine Arch-Douglas
PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 213-228; DOI: https://doi.org/10.5731/pdajpst.2018.009415
Parag Kolhe
1BioTherapeutics Pharmaceutical Sciences, Pfizer Inc, Chesterfield, MO 63017
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  • For correspondence: parag.kolhe@pfizer.com
Khurram Sunasara
1BioTherapeutics Pharmaceutical Sciences, Pfizer Inc, Chesterfield, MO 63017
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Lavinia Lewis
1BioTherapeutics Pharmaceutical Sciences, Pfizer Inc, Chesterfield, MO 63017
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Michele Bailey Piatchek
1BioTherapeutics Pharmaceutical Sciences, Pfizer Inc, Chesterfield, MO 63017
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Roberto Rodriguez
1BioTherapeutics Pharmaceutical Sciences, Pfizer Inc, Chesterfield, MO 63017
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Katherine Arch-Douglas
1BioTherapeutics Pharmaceutical Sciences, Pfizer Inc, Chesterfield, MO 63017
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References

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    International Conference on Harmonisation. Quality Guideline Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), 2012. ICH Web site. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf (accessed Aug 8, 2018).
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    The Dual Role of Lipids of the Lipoproteins in Trumenba, a Self-Adjuvanting Vaccine against Meningococcal Meningitis B Disease. AAPS J. 2016, 18 (6), 1562–1575.
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    U.S. Food and Drug Administration. First Vaccine Approved by FDA to Prevent Serogroup B Meningococcal Disease, 2014. FDA Web site. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm420998.htm (accessed Aug 8, 2018).
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    Australian Government Department of Health Therapeutic Goods Administration. Prescription Medicines: Registration of New Chemical Entities in Australia, 2017. TGA Web site. https://www.tga.gov.au/prescription-medicines-registration-new-chemical-entities-australia (accessed Aug 8, 2018).
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PDA Journal of Pharmaceutical Science and Technology: 74 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 2
March/April 2020
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Control Strategy Approach for a Well-Characterized Vaccine Drug Product
Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez, Katherine Arch-Douglas
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 213-228; DOI: 10.5731/pdajpst.2018.009415

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Control Strategy Approach for a Well-Characterized Vaccine Drug Product
Parag Kolhe, Khurram Sunasara, Lavinia Lewis, Michele Bailey Piatchek, Roberto Rodriguez, Katherine Arch-Douglas
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 213-228; DOI: 10.5731/pdajpst.2018.009415
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Pfizer's Approach to Development and Visualization of the Control Strategy
    • 3. Case Study: Trumenba
    • 4. Summary
    • Conflict of Interest Declaration
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Keywords

  • control strategy
  • ICH Guidelines
  • Product quality
  • Trumenba
  • Drug substance
  • Drug product

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