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Bispecifics

​From cell line development through manufacturing, Catalent has experience with over 25 bispecifics across a wide variety of formats, including:

  • Four different 4-chain formats
  • Two different 3-chain formats
  • Antibody fusion
  • Antibody 2-chain fusion
  • Single chain
  • Trispecific

GPEx® Cell line development technology is uniquely suited to enable development of bispecifics:

  • Enables genetic and expression stability of all genes needed to produce the molecule
  • Works in a variety of cell lines to enable the best expression
  • Ability to modulate ratios of protein expression through gene titration
  • High gene insertion efficiency
  • Reduces the need for multiple selection markers

Catalent Biologics provides the full range of biologics analytical capabilities across its network, with the ability to verify that the protein has the correct ration of the different chains:

  • Intact and de-glycosylated mass analysis by RPLC-HRMS
  • Impurity profile of bispecific antibody by RPLC-HRMS
  • Subunit analysis by RPLC-HRMS
  • Peptide mapping by RP-LCMSMS
  • Disulfide bond mapping by RP-LCMSMS
  • N-glycan profile by LC-FLR-MS
  • Secondary structure by FTIR
  • Secondary structure by Circular Dichroism
  • Intrinsic fluorescence