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Manufacturing of the Drug Product

  • John Geigert
Chapter

Abstract

The CMC regulatory compliance impact of the manufacture of the biopharmaceutical drug product due to the choice of formulation composition, coupled with the choice of the product-compatible container closure system, is examined. Also, the various manufacturing processes to conjugate a protein to a chemical (e.g., PEGylation) or to a drug (e.g., ADC) prior to formulation is discussed. The criticality of carrying out the filling and sealing process of the drug product under GMP aseptic conditions to obtain sterile injectable biopharmaceutical drug products is presented.

Keywords

Pegylation Conjugation ADC Formulation Container closure Aseptic processing Compatability Extractables Leachables Sterile filtration 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • John Geigert
    • 1
  1. 1.BioPharmaceutical Quality SolutionsCarlsbadUSA

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