Table 1 Product quality attributes of purified harvest material
Product quality attribute | Commercial scale reference sample | SDM verification run 1 | SDM verification run 2 | SDM verification run 3 |
|---|---|---|---|---|
Oligosaccharide mapping | Profile comparable to standard | Profile comparable to standard | Profile comparable to standard | Profile comparable to standard |
Purity by size exclusion HPLC | ||||
Monomer [%] | 99 | 100 | 99 | 99 |
Aggregate [%] | 1 | 0 | 0 | 1 |
Fragment [%] | 0 | 0 | 1 | 0 |
Monomer pattern by capillary gel electrophoresis | ||||
Monomer [%] | 97 | 97 | 97 | 97 |
Light and heavy chain pattern by capillary gel electrophoresis | ||||
Light chain + heavy chain [%] | 99 | 99 | 98 | 99 |
Acidic species by cation exchange chromatography | ||||
Acidic species [%] | 30 | 30 | 28 | 32 |