Manufacturing
Jivi is produced by recombinant DNA technology in baby hamster
kidney cells1*
Jivi manufacturing process1*
rFVIII gene
Recombinant production cell line is propagated
Harvest isolation process
Anion exchange chromatography
+ 20 nm viral filtration of tissue culture fluid
Conjugation to the PEG moiety (60 kDa)
The 60 kDa dual-branched PEG molecule is conjugated at the A3 domain (K1804C)
Chromatography + ultrafiltration to separate mono-PEGylated
Jivi active molecule from product-related species
Recombinant B-domain deleted
PEGylated human coagulation FVIII
Adapted from Jivi Product Monograph.
No human- or animal-derived components are added to the cell culture process, purification, site-specific PEGylation and final formulation1
rFVIII=recombinant Factor VIII.
* Clinical significance is unknown.
