

Overcoming CMC challenges of IgM
|
Problem description |
Canton Biologics solution |
|
IgM titers are far below the benchmark of IgG molecules |
Canton Biologics Cell Line and Vector Technology |
|
Hexamers impurities in addition to naturally pentameric IgM |
Ratio optimization of the involved chains |
|
IgM exhibits lower binding to affinity chromatography compared to IgG |
Established a high yield DSP platform & replace AC in case of insufficient binding |
|
Complexity and size of the molecule |
Profound understanding of broad method portfolio |
|
Many disulfide bond and free cysteins |
Advanced MS-MS for characterization |
|
IgM is more prone to aggregation |
Efficient platform formulation + optimization |
|
Long out-of-fridge and preservative |
Experienced formulation development team |