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Biopharmaceutical Source Materials

  • John Geigert
Chapter

Abstract

The source material for a biopharmaceutical contains the genetic capability of producing the biopharmaceutical product. The main focus of this chapter is on the source materials for manufacturing (1) the recombinant proteins and monoclonal antibodies (i.e., cell banks), and (2) the genetically engineered viruses used in gene therapy (i.e., cell banks, virus banks, plasmid vectors). Also, in this chapter, three myths about the recombinant cell banks are debunked: (1) a Master Cell Bank used to manufacture an early stage clinical development biopharmaceutical is perfectly acceptable for use in commercial manufacture of that biopharmaceutical, (2) exchanging out a Master Cell Bank during clinical development is not a major risk, and (3) a Working Cell Bank never causes manufacturing problems.

Keywords

Cell bank Virus bank Vector bank MCB WCB MVB WVB Myths 

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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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