In order to ensure patient safety, the regulatory authorities recommend the detection and quantification of impurities in biological products for therapeutic use. The potential contaminants include host cell DNA and host-cell proteins (HCP) from the production cell line and proteins from the culture medium and purification process.

 

 

 

• Residual DNA qPCR assays:

 

- Hamster (CHO)

- Human (HEK293, MRC5)

- Monkey (VERO)

- Mouse (Sp2)

- Avian (duck and chicken cells)

- Insect (Sf9, Sf21)

- Bacteria (E.coli)

- Yeast (Pichia pastoris)

 

 

 

• Residual proteins ELISA methods:

 

1. Host Cell proteins (HCP)

 

- Bacteria (E.coli)

- Hamster (CHO)

- Human (HEK293, A549)

- Mouse (NS/0)

- Yeast (Pichia pastoris)

 

1. Others impurities

 

- Benzonase^®

- Bovine Serum Albumine (BSA)

- A protein

 

 

Please, click on the titles to download our technical sheets and know more about our methods