Residual Impurity Testing
Since biopharmaceuticals are manufactured using cultured cells, impurities derived from the manufacturing process may remain.
Impurities derived from the manufacturing process are as follows:
- Cell substrate (host cell protein, host cell DNA)
- Cell culture (antibiotics, serum, other medium ingredients)
- Separation or purification process (affinity ligand, etc).
Host cell protein, host cell DNA, and ligand, which are impurities derived from the manufacturing process of antibody drugs, are quantified using ELISA or PCR.
|Compound Name||Analytical Method|
|Host Cell Protein||ELISA|
|Host Cell DNA||qPCR|