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Monoclonal Antibody Impacted through Exposure to Polymeric Materials of Construction Sterilized through Gamma Irradiation

  • At: 2017 FIP Congress in Stockholm (Sweden)
  • Type: Poster
  • By: MIFKOVICH, Cassandra (Merck & Co., Inc, Sterile Liquids Commercializatoin, West Point, United States)
  • Co-author(s): Cassandra Mifkovich: Sterile Liquids Commercializatoin, Merck & Co., Inc, West Point , United States
    Nancy Schaffner: Merck Sharp & Dohme, Boxmeer, Netherlands
  • Abstract:

    Backgrounds

    Compatibility studies for product contact materials are routine studies completed during drug development; for these studies, multiple assays are used to evaluate the impact to the product after exposure to the product contact material.  Initial evaluations of a select monoclonal antibody (mAb) found that the method of sterilization –..

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Last update 4 October 2019

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